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Click here or scroll down to respond to this candidate SUMMARYQA, Validation Specialist/Lead, Business Analyst, and Compliance Specialist with CSV, Pharmaceutical IT, Product & Device Manufacturing, CAR-T Manufacturing, Cleaning Validation, and Software QA experience with extensive experience in QA/Compliance, Testing, SQA, PM, System Software & Instrument Validation Documentation and UAT, FAT, and SAT testing and working with Regulatory Affairs, Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC), submissions and content management applications. Testing experience: Consist of performing and managing the testing related to data migration, cleaning validation, Installation and Operational Qualification (IQ/OQ), System Integration Testing (SIT) and User Acceptance Testing (UAT) on various Pharmaceutical applications/systems e.g.; LIMS, Star LIMS Labware ELN, CTMS, CAPA, CRM/financial, ERP, SAP manufacturing, MPM, PDM, training applications/LMS systems for COTS and In-house systems and instrument qualification, validation, calibration, commissioning and decommissioning of various lab equipment, Drug Supply Chain, Security and eQMS (Electronic Quality Management System) for J&J, BMS, Merck, Sanofi and ImClone. Experienced in developing various clinical, manufacturing, Asset Management, Maximo, CAPA, CRM, ERP, MES, PLM SAP, Pharmacovigilance, Labeling & Packaging Systems Supply Chain systems, various SAP modules such as the (QM), (TM), (GDP) (PLM), (MM), (PM) (MDM), SAP S/4HANA, SAP Environment Health Safety (EHS), Laboratory Equipment qualification, Veeva Vault, eQMS, RIM, CRM, Connector, remediation of various IT, manufacturing, clinical, labeling and package & CRM systems, test approaches, System, Functional and User Requirement & Configuration Spec s, Val Plan s, GxP Assessments, Risk Assessments, test protocols, (IQ OQ, PQ,) SIT and UAT test scripts/test cases, Summary Reports, Medra, E2B reports, RTM s, operational and maintenance SOP's, Serialization Master Data (SMD) Specifications, Serialization Requirements, developing workflows, process maps, application and administration SOP s, Data Management and Data Migration spec s, provided support during Hypercare period, Electronic Common Technical Documents (eCTD) submissions for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research, Activity & Support Diagrams, validation and testing of clinical trial systems / (discovery/diagnostics drug testing), dilution system testing, critical reagents testing, familiar with cell gene therapy CSV, supply Chain validation and initiating change controls for implementation of new systems and instrumentations. Carry out dry runs for system development and to weed out possible requirement, script or test errors prior to formal execution. Extensive experience with Argus safety database and PV Operations, including configuration, reporting, support and maintenance. Experienced in ensuring manufacturing complies with applicable procedures, reviewing and approving batch records, product labeling and packaging, reviewing of various manufacturing/shop documentation, cleaning validation involving biologics and authoring, reviewing, executing and approving cleaning validation documentation, involving Sampling Plans, Acceptance Criteria Determinations reviewing and analyzing data, interfacing with Quality, and review investigations, interpret results and generate technical conclusions. Laboratory Instrument Qualification/Lab Equipment validation experience: Consists of validating UV/Vis spectrophotometer instrument systems, Plate readers, chromatography instruments such as HPLC, UPLC and GC Gas Chromatograph instrument systems. Mass Spectrometers, Nicolet FTIR 4700 & 6700, Mixing Stations, Isolators, Bioreactors, Fume Hoods, Agilent UV-Vis ChemStations, that feed data to various Laboratory Information Management Systems that I validated such as Watson LIMS, LIMS Sample Manager and Water's Empower. I performed Electronic Laboratory Notebook (ELN) validation used on various LIMS and Water's Empower systems and validated Electronic Experiments (eE) and laboratory templates. Labeling/Packaging experience: Consists of creating labels in SPL and PLR format and verifying and ensuring the integrity of these product labels were compliant with PDMA to minimize the risk of recalls due to misbranding and potential subsequent regulatory citations. IT/QA Management experience: Consists of managing CAPAs, developing processes, flows and authoring guidelines to support role base training plans, internal and external audits and inspections in an IT environment. Managed the development/revision and reviews of various documentation, forms and templates in Veeva Vault, Documentum, FirstDoc and Pilgrim for LIMS, Labware ELN, CTMS, CAPA, CRM, financial, ERP, MES, training/Learning Management Systems, (ComplianceWire), COTS and In-house systems. Managing the validation, compliance, implementation writing, reviewing and approving of validation documentation. Involved in execution of software, installation of hardware, qualification of infrastructure and resolving testing and compliance issues on various projects for Sanofi, Merck, J & J, Warner Chilcott, Imclone Systems, BMS, ICON and Systech International. Quality Management System ISO9000, Compliance Quest, Total Quality Management (tQM). IT/QA Compliance Management experience: Consists of managing various projects involving applications ranging from MES, ERP, CTMS, PLM, CRM, LIMS, CAPA s, Pharmacovigilance and Drug Supply Chain systems and handling of deviations, Non-conformance process issues related to these applications. Working with the following FDA standards, cGMP, GDP,GCP, GLP, CBER, GAMP4 & 5, HIPAA, PDMA, EMEA, Drug Supply Chain Security Act (DSCSA), Drug Quality and Security Act (DQSA)1, National Drug Code (NDC), Council for International Organizations of Medical Sciences (CIOMS), ICH, ASTM E2500, e-Pedigree (an electronic document which provides data on the history of a specific batch of a drug which satisfies the requirement for a drug pedigree), European Union Medical Device Regulations and International Serialization regulations. Involved in audits and inspections, identifying regulatory/compliance issues involving new & existing computer systems and software involving, CAPA, security, clinical trial, financial, product sampling, labeling, packaging, manufacturing systems, HA submissions. Administering/managing of Quality Assurance projects involving various validation documentation, procedures, testing and training documentation. Business Analyst experience: Consists of writing business workflow processes and translating them into Business, Functional and User Requirements, User Stories and SOP s. Act as the key liaison between the business owner and technical team to architect solutions in finalizing Business, Functional and User Requirements, testing strategies and gain system approval of Labeling, Financial, Information Management, Resource, Manufacturing, Pharmacovigilance, Biopharma, CTMS, CRM, LIMS, eQMS, HR, Data Management, Oracle and Clinical and Nonclinical R&D systems. Proficient in analyzing a systems Business, Functional and User requirements, implementation and process improvements in a Clinical and Nonclinical R&D environment for Bio-Pharmaceutical domain, Medical Devices, and Supplier Management processes for compliance with EU MDR regulations.
Proficient in Business, Functional and User requirement gathering and performing requirement analysis using Blueprint and CaliberRM tool. Experienced with Business Process Modeling and Data Modeling for clinical and nonclinical R&D systems Drug Supply Chain experience: Consists of managing the validation testing and implementation of SAP SCM 7.0 a Drug Supply Chain system at Amgen & Merck. The Supply Chain functions involved the purchasing, manufacturing, warehousing, transportation, customer service, demand planning, supply planning and Supply Chain management. Methodology, followed the four 4 main elements of Supply Chain Management, Integration, Operations, Purchasing and Distribution to be cost-effective and competitive and adhered to the Drug Supply Chain Security Act (DSCSA) and corporate standards and policies. System Development Life Cycle (SDLC) experience: Consists of managing each phase of the SDLC process and verifying that all applicable SDLC documentation and testing has been completed and approved before releasing an application into a production environment. IT Infrastructure Library (ITIL) experience: Consists of following, documenting and managing ITIL lifecycle model; Service Strategy, Service Design (models for productive operation), Service Transition (service implementation/launch), Service Operation (productive operation of services) and Continual Services Improvement guideline that all define how to plan, deliver and support IT service features. Technical Writing experience: Consists of creating and updating SOP s involving software, hardware, product sampling, manufacturing, lab instruments, various manufacturing equipment, receiving, product handling, calibration, operation and preventive maintenance plans, validation documentation such as; Validation Plans, Test Protocol Plans, Project Charters, Quality Plans, System & Integration Plans, Data Conversion Plans, SRS s, URS s, FRS s, SDS s, RTM s, FAT s, SAT s, SIT's, UAT s, and Summary Reports. Created/updated User Stories, Acceptance Criteria's, manuals involving User Software, System & Security Administration, Help Desk, Electro/Mechanical drawings and specifications related to lab and manufacturing equipment, construction, HVAC, Parts Illustrated, Assembly, Installation, Maintenance/Service & Operating manuals. Other types of documentation involved programming standards, process guidelines, policies, test equipment, training material, guides, retirement documentation, forms and brochures.Achievements:. Successfully achieved validation/production approval of the following applications/systems: Amgen - ALM v15.5, Siebel CTMS Clinical Trial Management System, Veeva Vault QMS, RIM, CRM, Connector, ARISg & Argus a Pharmacovigilance Safety application, MES, ERP, LIMS, SAP Solution Manager and various other modules such as (QM), (MM) & (PLM), SAP SCM. 8.8. 6.7 Drug Supply Chain Systems like SAP S/4HANA, Labeling & Packaging Systems, Maximo, PeopleSoft, CAR-T Manufacturing, recently Validate & Implemented Veeva Quality Management System (QMS) and currently using Veeva QMS and provide oversight to ensure various computerized systems are deployed and following the Lifecycle Management mythology, SDLC, and making sure all systems remain in a validated state by following SDLC, IT mythology. Currently Using Veea QMS to writing, reviewing and approving Change Controls, Deviations and various documentation e.g. Design, Requirement & Configuration Specifications, Validation Plans Test Protocol Plans, Test Scripts. Traceability Matrix, Summary Reports, SOP's etc. per associated regulatory and security requirements. Currently providing QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system) and additional GxP systems for Gene Therapy manufacturing and other type of product manufacturing and for other system e.g., LIMS, SAP, Supply Chain, Pharmacovigilance, Biopharma, CTMS, CRM, LIMS, eQMS, HR, Data Management, Oracle and Clinical and Nonclinical R&D systems. Merck Watson LIMS v7.6.1, Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System, istudyReporter, SAP S/4HANA, SAP Manufacturing and modules (QM), (PLM), (MM), (PM) (MDM) SAP SCM. 8.8. 6.7 Drug Supply Chain. Sharp Packaging Systech, labeling and package line automated software system. Sanofi Watson LIMS v7.5, a clinical data management system used to create/design (PK, TK, PD) clinical and nonclinical studies. (CAPA project), LMS, SharePoint, SAP R/3, SAP S/4HANA, ARISg & Argus a Pharmacovigilance Safety, cleaning validation. J&J Siebel CTMS Clinical Trial Management System & CRM applications involving SalesForce, Siebel, Managed Marks, Territorial Management and Customer Call Center interfaces, SharePoint, eTMF, PLM, SAP Manufacturing and modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PM) & (SD) Solution Manager, Master Data, Financial module, Argus 7.5 Pharmacovigilance Safety System and LMS application. Schering-Plough Prosit, a clinical data management system for entering and tracking clinical trials/studies. Pfizer Validation and production approval of various production servers & software. Schindler Elevator achieved ISO 9000 certification.
BMS Maximo, LIMS Sample Manager, Empower, LMS, TrackWise, PLM SAP Manufacturing and the following modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PI), (PM) & (SD). Systech International Inspection/Vision Solution & Labeling & Packaging System. ICON ARISg & Argus a Pharmacovigilance Safety System that tracks, processes, and reports on Adverse Events. ImClone Watson LIMS, a clinical data management system used to create/design (PK, TK, PD) clinical and nonclinical studies, Argus 6.0 Pharmacovigilance Safety System, CAPA's Warner Chilcott TrackWise v8.4.1, Argus 6.0 a Pharmacovigilance Safety System and CAPA'sSTANDARDSFamiliar with FDA standards: 21CFR Part11, 58, 99, 111.27(d), 160, 201, 203, 207, 210, 211, 211.67(d), (211.122(g) 125, 130, 132,134, 137), 198, 314.80, 803, 806, 820 & 820.70(e) 21 CFR 211.67(a), 21 CFR 820.30, 21CRFR1271, ISA S88 & 95, IEC 62304, ISA95 standard, GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO9000, ISO9001, ISO13485, ISO19227, ISO14971, ISO 27001, & ISO 17025:2017, CSV, SOX 302,404, HIPAA, PDMA, ASTM E2500, ICH, Q8, Q9 & Q10, xEVMPD, IDMP, H R 3204 Drug Quality & Security Act, Prescription Drug User Fee Act (PDUFA III), Drug Quality and Security Act (DQSA)1, IEC 62304, 62443, 62443-4-1, 62443-4-2, 62443-3-3 and IEC 60601-1 Medical Device Marking and Labeling standard, ISO 14791 European Union Medical Device Regulations (EU MDR), Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) Regulatory Submission, ISO 15223-1:2012 Medical devices Symbol standard, Drug Code (NDC), Identification of Medicinal Products (IDMP), eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), HL7 standards, ISOISP standards, Electronic Submission Regulation (EC) No. 726/2004 Article 57(2), second subparagraph, Drug Supply Chain Security Act (DSCSA), ANSI/HL7 V3 SPL, R4-2009, ICH M2 EWGDATABASE, OPERATING SYSTEM, WEB & SOFTWARE EXPERIENCE Databases: Oracle, UNIX. Operating Systems & Web Environments: Windows XP, MS Windows 07, Windows NT 4.0, Mac 7.1, Explorer & AOL. Software: Watson LIMS 7.4.1, 7.5, & 7.6.1 Maximo 6.2, ARISg 5.0.2, Argus 5.0,6.0, 7.0, 8.0, 8.1, Siebel 7.8-8.1 LIMS Sample Manager 2004, Labware ELN, TrackWise 6.0, 7.0 & 8.0, e Doc, Documentum D2, 6.5 & 7.0, Veeva Vault 21R3.1, Training/Learning Management Systems, (ComplianceWire), Kallik s Artwork Management Solution (AMS), GxPharma, SAP R/3 & ECC6 Systems, PLM, SAP s (PLM), (EHS), (QM), (TM), (GDP), and Solution Manage modules, PeopleSoft, Remedy 5.0, Analyst, Empower, Chemstation, Xcalibur, Six Sigma, AS/400, Word, MS Office, Excel, Access, PowerPoint, MS Project, Outlook, Visio, D2LMS, SharePoint Records & Document Management System, Application Lifecycle Management (ALM) 11.5 & 15.5, Pilgrim, Salesforce, MS Dynamics, Oracle v11.2.0.3.0 and Oracle E-Business Suite v12, Spectrum 4.0, SharePoint, TrackWise, Veeva Vault, Veeva CRM, Veeva RIM, SAP SCM 7.0, SAP S4/HANA, eQMS (Electronic Quality Management System)
SoftwareTools: HP Quality Center & ALM, SharePoint, ETQ, SQL, Quick Test Pro, LoadRunner, Blueprint and CaliberRMPROFESSIONAL EXPERIENCE:Amgen Thousand Oaks CA 10-20 to PresentQA Manager / Compliance Specialist / Validation Specialist / BA (Consultant) Supporting and managing the Validation, remediation and Qualification of various computerized systems such as LIMS, ALM 15.5, Pharmacovigilance Systems, Salesforce, PeopleSoft, Veeva Vault RIM, CRM, SAP S/4HANA SAP PLM, QM, TM, GDP, MM, Quality Management System (QMS), PeopleSoft, Asset Management, Maximo, ComplianceWire a Learning Management System, and electronic trial master files (eTMF), Clinical Trail Management Systems (CTMS), SAP, ERP, Star LIMS, Labeling & Packaging Systems involving labeling & serialization, of products, medical devices, Salesforce, Supply Chain Systems, Manufacturing Systems (MES), cleaning validation involving biologics, authoring, reviewing, and approving validation documentation, analyzing data, Sampling Plans, Acceptance Criteria Determinations, investigations, interpret results and generating technical conclusions and reviewing and approving batch records. Lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GMP and non-GMP environment, supporting periodic review effort on past validations and CAPA's and IT support. Currently using TrackWise to create and approve Change Controls, verify QA status on various projects related to Implementation, documentation, Assessments, execution, deployment etc. Extensive experience with Argus safety database and PV Operations, including configuration, reporting, support and maintenance and SharePoint experience, Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC). As the QA Compliance Specialist and Validation Specialist/Lead I am involved in contributing to performing dry run testing, writing, reviewing and approving of Requirement Specifications, Validation Plans, IO, OQ PQ and UAT Test Protocol Plans, Traceability Matrices, Summary Reports, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized systems and lab instruments. Adhering to various regulations e.g.; GAMP5, GxP, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 19227, 13485, 14971, 9001, 27001, & ISO 17025:2017, IEC 62304, 21 CFR 820.30, 21CFR Part11, 21 CFR 211.67(a), CMC Regulatory Submission, Veeva Vault, eQMS, RIM, CRM, Connector, EU MDR, SOX, and working with Regulatory Affairs, submissions and content management applications.. Managing vendor's, involving audits, documentation, pre & post testing, CRO's and clean validation. Involved in performing pre and post review of IQ, OQ, PQ and UAT testing, documenting and resolving defects, writing, reviewing and approving various documentation in Veeva Vault QMS. Veeva CRM and Salesforce a Customer Relationship Management application that handles account management, primary care, pharmacy sales, field medical tasks, and coordinators events. Involved in approving Change Controls using TrackWise and ServiceNow for IT Change Management and working with Veeva RIM a Regulatory Information Management System used to manage product, registration, document submissions, archiving and health authority correspondences and commitments.MERCK Rahway NJ 10-19 to 04-21IT/QA / Business Analyst / Validation Specialist / Compliance Specialist (Consultant) Supported and managed various projects as the Business Analyst gathering and developing Requirement Specifications, Process Workflow Diagrams, Risk Assessments, Validation, Remediation and Qualification of various computerized systems and lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GMP and non-GMP lab environment, supported and validated the eQMS (Electronic Quality Management System), periodic review effort on past validations and CAPA's and IT support. Adhering to various regulations e.g.; GAMP5, GxP, GMP, cGMP, GCP, GLP, SOX, QSR 21, MDD, ISO 13485, 14971 & 9001, 21CFR Part11, work with Regulatory Affairs, CMC Regulatory Submissions and content management applications. Managing vendor's, involving audits, documentation, pre & post testing and CRO's and Cleaning validation. As the Validation Specialist/Lead and Business Analyst I am involved in contributing to the dry run testing, writing, reviewing and approving of Requirement Specifications, Validation Plans, IOQ and UAT Test Protocol Plans, Traceability Matrices, Summary Reports, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized lab instruments. Involved in performing IOQ and UAT dry run testing, pre and post review of IOQ and UAT testing, documenting and resolving defects, writing, reviewing and approving Change Controls and corrective action approvals of defects. Also involved in the validation upgrade of Watson LIMS v7.4.1 to v7.6.1, istudyReporter, ELN, SAP S/4HANA and the following modules, Finance (FI), Controlling (CO), Sales and Distribution (SD), Material Management (MM), Production Planning (PP), Material requirement planning (MRP), Quality Management (QM), Plant Maintenance (PM), Project System, (PS), Product Lifecycle Management (PLM), Environment, Health, and Safety (EHS), Master Data Management (MDM), Verification of the Validation and archiving of Trial Master Files (eTMF), Veeva Vault eQMS, RIM, CRM. Windows 7 to Windows 10 upgrade on various computerized instrument stations and PLM a Product data platform. Tasks involve evaluating if instrument software is compatible with Windows 10, contacting vendor to verify if they have software that is compatible with Windows 10, installation of Window 10 software, Maximo and validation and requalification of instrument stations.SHARP PACKAGING Allentown PA 7-18 to 7 19Quality Assurance / Validation Expert (Consultant) Supporting and managing the Quality Assurance and Validation/remediation of the labeling, serialization, inspection, and equipment and software qualification of computerized labeling and packaging and automated equipment systems for various pharmaceutical products in a GxP environment and supply Chain validation. Adhering to cleaning and manufacturing regulations/standards e.g.; GMP, cGMP, ISO 9001, 19227, 21CFR Part11, 21 CFR 211.67(a) EU MDR. As the Quality Assurance and Validation Expert I am involved in contributing to the testing, writing, reviewing and approving of Serialization Master Data (SMD) specifications, plans and Requirement Specifications, Validation Plans, Testing Strategies, IOQ and UAT Test Cases, Traceability Matrices, Summary Reports, Serialization Plans, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized labeling and packaging and automated equipment systems for various pharmaceutical products for Sharp Labeling and Packaging. Managed vendor's involving audits documentation, pre & post testing and CRO's. Involved in performing IOQ and UAT testing, pre and post review of IOQ and UAT testing, documenting and resolving defects, writing, reviewing and approving Change Controls and quality agreements. Currently using Pilgrim for pre and post reviews for approving various documentation involving IOQ and UAT executions and for tracking corrective action and approvals of defects.SANOFI, Bridgewater NJ 5-17 to 6-18Quality Assurance / Validation Expert (VEX) / Business Analyst (Consultant) Supported and managed the Quality Assurance and Validation/ remediation of various software applications and data migrations that were GxP and Non-GxP related projects per SANOFI s PUMPA methodology. Supported the review and corrective action of CAPA's, performed Periodic Reviews on various projects involving reviewing all types SDLC/PUMA documentation and discovery/diagnostics drug/cell gene therapy, CMC Regulatory Submissions, CSV testing and validation of Veeva Vault eQMS, RIM, CRM. Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC). As the Business Analyst, Quality Assurance and Validation Expert I was involved in contributing to the testing, writing and approving of Requirement Specifications, Validation Plans, Architecture and Configuration Spec's, develop workflows, process maps, Data Migration Plans, Technical Recovery Plans (TRP s), System Retirement Plans, Testing Strategies, Test Cases, Traceability Matrices, Training documents, Authorization of Use, System Integration Test Designs, User Acceptance Testing Designs, SIT and UAT Test Cases and, various reports.
Installation Qualification Reports (IQR), Data Migration Reports (DMR), SIT, UAT and Final Validation Reports for various applications e.g.; Watson LIMS, Labware ELN a Clinical Data Management System, PeopleSoft, ARISg & Argus a Pharmacovigilance Safety System, SAP R/3, SAP S/4HANA, eDoc, FirstDoc and Documentum a Doc Management System, worked on Sanofi's Learning Management System (LMS) and instrument qualification, validation, calibration, commissioning and decommissioning verification and initiating change controls, writing and updating User Requirements, protocols, reports, operational and preventive maintenance SOP's related to various lab equipment for the systems mention above, cleaning validation authoring, reviewing, and approving validation documentation, analyzing data, Sampling Plans, Acceptance Criteria Determinations, investigations, interpret results and generating technical conclusions. Involved in pre and post reviews of SIT, UAT and Migration Test Case executions, defects and writing, reviewing and initialing and approving Change Controls, Risk Assessments, quality agreements, validation and archiving of Trial Master Files (eTMF) and monitoring SIT and UAT testing. Tracked the corrections and approvals of defects using Application Lifecycle Management (ALM), Serves Now, e Doc and First Doc for documentation.MERCK, Rahway NJ 3-16 to 1-17Business Analyst / Validation Specialist / IT/QA Compliance Specialist (Consultant) Responsible for handling Business Analyst tasks and managing/supporting the validation/remediation effort for Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System (CTMS) SAP s (QM), Labware, ELN and PLM a Product data platform. Business Analyst tasks involve gathering requirements, updating and approving Requirements & Configuration Specifications, developing workflows, process maps, pre and post reviews and approvals of test scripts, investigation and closure of defects and data analysis. SDLC risk base approach computer validation methodology was being followed for this project. Other tasks involved calibration, commissioning and decommissioning on various laboratory equipment for Spectrum a CTMS system and validation of Veeva Vault QMS, RIM, CRM and reviewing and approving batch records. Adhering to various regulations e.g.; GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 13485, 14971 & 9001, 21CFR Part11, and a lot more. Involved in system change control reviews and approvals, risk assessments, coordinating and performing execution/qualification of infrastructure, application, management of CAPAs, support internal audits related, data Migration for UAT testing and ensured Spectrum application was compliant with internal company policies, procedures and compliant with GCL and 21CFR Part 11 regulatory regulations. Managed offshore testing team of 5 people for CSV team that involved pre and post review and approval of test scripts, test defects and testing of Spectrum 4.0. Used Application Lifecycle Management (ALM) for pre and post reviews, for SIT and UAT executions and tracking of defects and managed the development/revision and reviews of various specs, procedures, forms and templates related to clinical trials. Supported and managed the Quality Assurance of various validations involving products discovery/diagnostics drug testing), dilution system testing and training documentation that supported our training plans. Updated and generated new training material e.g.; user guides, job aides and author guidelines, ensuring our training plans were updated in our Learning Management System and managed the development/revision and reviews of various documentation, forms and templates all related to clinical trials. Tracked execution of pre and post reviews and approvals of test scripts, investigation and closure of test defects encountered during testing. Verified business and regulatory requirements were adequately satisfied and verified our systems and processes were compliant with our internal SOP's, external regulatory regulations and audit compliance industry best practices.
GUARDIAN, Bethlehem, PA 6-15 to 3-16Business Analyst / Validation Specialist, IT/QA Compliance Specialist (Consultant) Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, User Stories and involved in developing the test strategy/approach for the STP application. The SDLC risk base approach/methodology is being followed to archive production approval. Working with business owners, underwriters, processors and technical team to help manage projects, write, review and approve Business, Functional and User Requirements, Configuration Spec, develop workflows, process maps, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms, perform Gap Analysis, create workflow and maintenance SOP s. Involved in Configuration, Implementation and Change Control process in support of the validation effort for the STP application used to process applications for insurance. Other responsibilities involve performing pre and post reviews and execution of IQ, OQ, PQ/UAT testing of STP application, verifying that the STP application through testing is compliant with state and HIPAA regulatiions and involved in system research and analysis for product and business improvement and future business needs.TELERX, Horsham, PA 10-14 to 12-14Business Analyst / IT/QA Compliance Specialist (worked as a Consultant) Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, created User Stories and Acceptance Criteria's and help develop the test approach for the Pega application. Worked with business owner and technical team to manage project, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, develop workflows, process maps, User Stories, Acceptance Criteria's, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms, Gap Analysis, workflow and maintenance SOP s, Configuration, Implementation and Change Requests in support of the validation effort for the Pega system a CRM MS Dynamics application used to process applications for medication for patients with or without Health Insurance and for people who can't afford to pay for their medication.
Other responsibilities involve helping manage the validation effort for Pega and performing pre and post reviews and execution of IQ, OQ, PQ /UAT testing and verifying that the Pega application was compliant with 21CFR Part 11 and HIPAA regulatiions.
inVentiv Health, Somerset, NJ 6-14 to 8-14Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, User Stories and Acceptance Criteria. Developing the test approach, performing System analysis and gathering data and migrating data to be utilized for UAT testing and production. Working with business owner and technical team to manage project, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, User Stories, Acceptance Criteria's, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM's, Summary Reports, forms, Gap Analysis, workflow and maintenance SOP s related to system, Configuration, Implementation and Change Requests in support of the validation effort for inSupport and Salesforce a CRM application used to process applications for medication for patients with or without Health Insurance and for people who can't afford to pay for their medication.
Other responsibilities involved managing the validation effort for PeopleSoft involving (Benefits, Human Resources Management System, Payroll), performing pre and post reviews and execution of IQ, OQ, PQ testing involving inVentiv Health s workflow SOX and 21CFR Part 11.JOHNSON & JOHNSON, Skillman & Somerville NJ & Fort Washington, PA 10-13 to 4-14Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Responsible for documenting and updating business workflow processes and translating them into Business, Functional & User Requirements and UAT Test Scripts. Developed test approach, performed System analysis, managed validation effort, data management and migration for UAT testing and production. I was involved in supporting and managing the Quality Assurance of various validation, testing and training documentation that involved supporting & maintaining role base training plans, updating and generating new training material e.g.; author guidelines, user guides and job aides that involved defining data collection and reporting standards. Ensured training plans were updated in our Learning Management System LMS-D2L application. Involved in the management of CAPAs and managing the development/revision and reviews of SOP's, standards, qualification protocols, reports, Analysis Certificates, forms and templates related to validation of clinical trial systems / (discovery/diagnostics drug testing), dilution system testing, critical reagents testing and supported internal audits.
Working with business owner and technical team to manage projects, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, User Test Scripts, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM's, Summary Reports, forms, Gap Analysis, workflow, maintenance SOP s, related to system, Implementation and Change Requests in support of the instrument and cleaning validation effort for the DISTEK OPT-DISS TM UV spectrophotometer Dissolution Testing Systems and Nicolet FTIR 4700 & 6700 spectrophotometer instrument systems. The DISTEK OPT-DISS TM instrument is a software operated multi-channel in-situ fiber optic-based UV spectrophotometer Dissolution Testing Systems that was used to measure the dissolution rates of pharmaceutical dosage forms and the Nicolet FTIR 4700 Omnic software operated spectrophotometer instrument system used to analyze the Infrared spectrum of test samples and raw materials identifying the Transmittance/Absorbance levels base on a selected range of the wavelengths. Validated UV/Vis spectrophotometer instrument systems, Plate readers and washers, refrigerators, incubators (thermal mapping), HVAC (Nitrogen, Compressed Air, Clean Steam), Water System, chromatography instruments such as HPLC, UPLC. GC Gas Chromatograph and single use Bioreactors instruments, Chrome skids, Tangential Flow Filtration (TFF), Ultrafiltration (UF) and Diafiltration (DF) systems, Mass Spectrometers, Nicolet FTIR 4700 & 6700, Mixing Stations, Isolators, Agilent UV-Vis ChemStation, that feed data to various Laboratory Information Management Systems such as Watson LIMS, LIMS Sample Manager and Water's Empower. I performed Electronic Laboratory Notebooks (ELN) validation for various LIMS systems and Waters Empower systems and validation of Electronic Experiments (eE) and instrument qualification, validation, calibration, commissioning and decommissioning verification, initiating change controls, writing and updating User Requirements, protocols, reports, operational and preventive maintenance SOP's related to the various lab equipment mention above. Other responsibilities involved managing the validation effort for Siebel CTMS, documenting labeling and packaging requirements, Quality Assurance Plans, Test Protocol Plans and managing test executions related to the validation of J&J's Artwork Management labeling & packaging Solution System. Ensured the integrity of the labeling and packaging of various medical devices and pharmaceutical products and verified they were compliant with J&J"s packaging and labeling requirements and related FDA regulations to minimizes the risk of recalls due to misbranding to avoid potential regulatory citations. I am also supported the validation and testing of an upgrade to Argus 7.5 a Pharmacovigilance Safety System also involving PV Operations, configuration, reporting, support and maintenance. Verified all documentation and testing was compliant with GxP, cGMP & 21CFR Part 11, PDMA, DQSA1, IEC 60601-1 and ISO 15223-1:2012. Performed pre and post reviews of test documents, Change Requests and reviewed and approved all documentation in SharePoint. Was involved with the validation for SAP Manufacturing and the following modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PM) & (SD) Solution Manager, Master Data.WARNER CHILCOTT (US), LLC, Rockaway, New Jersey 5-13 to 10-13Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Developed and updated business workflows, process maps, and translated them into Business, Functional and User Requirements and Test Scripts. Developed test approach, gathered data and migrated data to be utilized for UAT testing and production and managing the SDLC process. Worked with business owner and technical team to manage project, write, coordinate, review and approve Business, Functional and User Requirements, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM's, Summary Reports, forms, Gap Analysis, workflow and maintenance SOP s related to system, Configuration, Implementation in support of the validation effort for TrackWise 8.4.1, Application Lifecycle Management (ALM), Siebel a CRM application for Sales Force Automation (SFA), Managed Marks (MM), Territorial Management (TM) and Customer Call Center (CCC) interfaces and Argus 6.0 a pharmacovigilance safety System . Other responsibilities involved performing System analysis, managing the Change Requests process, managing the validation effort, performing pre and post reviews and execution of IQ, OQ, PQ testing involving various GxP, cGMP & 21CFR Part 11 applications. Performed internal and external audits, supported and managed the Quality Assurance of various validation, testing and training documentation that involved maintaining training plans, updating and generating new training material involving user guides and job aides. Ensured training plans were updated in our Learning Management System and was involved in management of CAPAs. Handled regulatory/compliance issues, reviewed and approved documentation in SharePoint and TrackWise and created requirements, test scripts and performed testing in HP Quality Center.IMCLONE SYSTEMS, Branchburg, New Jersey 3-12 to 4-13Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Developed and updated business workflow processes and translated them into Business, Functional and User Requirements. Created Test Scripts, Acceptance Criteria's, logical level data models, developed test approach, performed System analysis and gathered data and migrated data to be utilized for UAT testing and production. Managed the Quality Assurance of various documentation, testing and training programs. Worked with business owner and technical team to manage the project, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, Val Plans, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms, Gap Analysis, Data Management and Migration, System Related SOP s, Change Requests, Configuration and Implementation all relating to the validation effort for Watson LIMS v7.4.1 currently being used as a clinical and nonclinical R&D system. The intended use of this application involves the creating/designing of Pharmacokinetic (PK), Toxicokinetic (TK) and Pharmacodynamic (PD) studies and to facilitate the tracking, analysis and submissions of clinical and nonclinical study samples in accordance with GLP practices to detect an antibody or antigen in a sample and in accordance with ICH M2 EWG for submissions. Managed the development/revision and reviews of various documentation, standards, qualification protocols, reports, Analysis Certificates, forms and templates related to clinical trials, products, critical reagents and supported internal audits on various system. The nature of the methodologies utilized to perform the analysis is primarily immunological-based to detect an antibody or antigen in a sample. I was also involved in validating the electronic Trial Master File (eTMF) software and hardware design to facilitate the management of regulated clinical trial content, images, classification and retention of BioPharma Clinical Trials and various digital content related to pharmaceutical clinical trials and instrument qualification, validation, cleaning, calibration, commissioning, decommissioning, initiating change controls, writing and updating User Requirements, protocols, reports, operational and preventive maintenance SOP's related to the various lab equipment e.g. Nicolet FTIR 4700 & 6700 Spectrophotmeter, Mixing Stations, Isolators, and Ritter M9D AutoClave Sterilizer for Watson LIMS. Other responsibilities involved supporting and managing the Quality Assurance of various validations, testing and training documentation that supported & maintained role base training plans. Updated and generated new training material involving user guides and job aides. Ensured training plans were updated in our Learning Management System. I was involved in the management of CAPAs, and managing the development/revision and reviews of various documentation, forms and templates related to clinical trials. Verified and ensured product labels were compliant with PDMA to minimize the risk of recalls due to misbranding and potential subsequent regulatory citations. Validation and testing of instrument software that interfaced with Watson LIMS, Water's Empower, Electronic Laboratory Notebook (ELN) validation and Argus 6.0 a Pharmacovigilance Safety System. Internal and external audits, processed Change Controls, handled regulatory/compliance issues involving GCP, GLP, cGMPs & 21CFR Part 11 and reviewed and approved documentation in TrackWise.FOREST LABS, Jersey City, New Jersey 9-11 to 11-11Validation Specialist / Business Analyst (Consultant) Developed and updated Business, Functional and User Requirements and User Stories, business workflow processes by creating flowcharts, mapping diagrams; SOP s and help developed the test approach. I was the key liaison between the business owner & technical team to architect solutions that were compatible with the existing SharePoint Records & Document Management System. Coordinated and reorganized all of Information Solutions validation documentation within the SharePoint application. Performed the configuration, implementation and functional and UAT testing for SharePoint Records & Document Management System. Wrote and reviewed system related Business, Functional and User Requirements, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Report and help resolve issues involving the SharePoint Records & Document Management System. Performed Gap Assessments, Risk Assessments and wrote Change Requests, workflow SOP s and provided application support relating to the validation and production approval of the SharePoint Records & Document Management System used for the review and approval of all documentation.MEDIMEDIA, Yardley, PA 3-11 to 8-11Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Developed and updated Business, Functional and User Requirements, workflow processes by creating flowcharts, mapping diagrams. Help develop the Project Plan, created Test Scripts, Acceptance Criteria's, and logical level data models. Developed the test approach, performed System analysis and managed and migrated the data to be utilized for UAT testing and production. Carried out dry runs for developing the system for the validation team and developers to weed out the fixes suggested for system development and I was involved in the Implementation and Application Support process. Worked as the key liaison between the business owner & technical team to manage project, architect solutions that were compatible with existing system and practices. Coordinated the writing, reviewing and approval of Business, Functional and User Requirements, Val Plan, IQ, OQ, & PQ Test Scripts, Configuration Spec s, RTM, Summary Reports, SOP s, forms, testing of software/hardware and performed internal and external audits. Managed the Quality Assurance of various documentation, testing and training programs. Resolved application and system issues, wrote and approved Change Requests, Gap Assessments, Risk Assessments, used HP Quality Center to manage the testing effort and all documentation was reviewed and approved in Documentum. Supported Business Systems in a manufacturing, planning and supply chain role for the Material group. Worked closely with cross-functional teams to identify opportunities for improvement through system or other data sources to improve bills of materials, manufacturing specifications, reporting routing and business processes. Created project plans, standard work instructions, conduct group training for new processes and was involved in build analysis models/reports for standard business tasks. Coordinated the testing, validation effort and ensured all documentation and testing was compliant with FDA regulations, corporate standards and policies, SDLC process, 21 CFR Part 11, PDMA and GAMP 5 for Siebel a Customer Relationship Management (CRM) application which involved Sales Force Automation, Managed Marks, Territorial Management, Customer Call Center interfaces and help validated the SharePoint Records & Document Management System and used Blueprint to document and approve requirements.PFIZER INCORPORATED, Collegeville, PA 12-10 to 2-11Business Analyst (Consultant) Developed and updated Business, Functional and User Requirements, workflows process maps, creating flowcharts and user stories. Help develop the Project Plan and the test approach, Worked as the key liaison between the business owner & technical team to coordinate the writing, reviewing and approving of Business, Functional and User Requirements, User Stories, Acceptance Criteria's, Val Plans, Configuration Spec, I/Q, OQ, & PQ Test Scripts, RTM, Summary Reports, Change Requests, Gap Analysis and Implementation involving the validation of the SAP Financial & Solution Manager module and SharePoint Records & Document Management System. Ensured all documentation and testing was compliant with corporate standards, policies, 21 CFR Part 11 and GAMP 5. Reviewed and approved all documentation in Documentum and this effort involved using GxPharma, BluePrint, HP Quality Center.JOHNSON & JOHNSON, Raritan, New Jersey 5-10 to 10-10Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Performed instrument qualification, validation, execution of clinical protocols, calibration, cleaning, commissioning and decommissioning on various laboratory workstations connected to external clinical R&D systems, discovery/diagnostics drug testing, dilution system testing. The workstations involved various instrumentation, test equipment and software such as the Convergent Biosscience iCE280 Analyzer, PrinCE Autosampler with a Micro injector utilizing the Convergent Biosscience iCE280 CFR v2.3 and Chrom Perfect software and the SpectraTest Jasco FP6500 Spectro Fluorometer utilizing the Spectro Manager CFR v2.08 software, Biotek Plate Readers and validation of refrigerators, incubators (thermal mapping), HVAC (Nitrogen, Compressed Air, Clean Steam), Water System, Washers, Mixing Stations, Isolators, HPLC and GC lab equipment and Mass Spectrometers and initiated change controls, writing and updating of User Requirements, protocols, reports and operational and preventive maintenance SOP's related to the various lab equipment mention above. Interfaced with various departments as well as vendors, contacted with lab personnel to obtain applicable procedures, manuals, drawings, service level agreements and documentation necessary to generate applicable calibration, operation, and maintenance SOP s. Performed internal and external audits, supported and managed the Quality Assurance of various validation, testing and training documentation that involved supporting & maintaining role base training plans, updating and generating new training material involving user guides and job aides. Ensured training plans were updated in our Learning Management System, was involved in the management of CAPAs, managing the development/revision and reviews of various documentation, forms and templates. supported internal audits on various systems and handled regulatory/compliance issues and involving e-Pedigree and International Serialization regulations and H.R. 3204. Developed and updated Business, Functional and User Requirements, workflow processes by creating flowcharts, workflow SOP s, Project Plans and acted as the key liaison between the business owner & technical team to architect solutions that were compatible with the existing system and practices. Created logical level data models and managed and migrated data to be utilized for UAT testing and production.
Manage the project, coordinated the writing, reviewing and approval of Business, Functional and User Requirements, Test Scripts, Acceptance Criteria's, Val Plans, I/Q, OQ, & PQ Test Scripts, RTM, SR, Change Requests, Configuration Spec s, Implementation and Application Support all relating to the validation effort involving the SharePoint Records & Document Management System and Argus 6.0 a Pharmacovigilance Safety System. Reviewed and approved data results, wrote and maintained SOP s related to SharePoint and various other system/software to ensure vendor software, documentation and testing was compliant with corporate standards, policies, 21 CFR Part 11, 820, Annex 11 and GAMP 5. Reviewed and approved all documentation in the SharePoint Records & Document Management System and oversaw the validation effort for the SharePoint Records & Document Management System and Argus 6.IMCLONE SYSTEMS, Branchburg, New Jersey 6-09 to 4-10Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Developed and updated business workflow processes and translated business requirements into detailed technical requirements. Created Test Scripts, Acceptance Criteria's, worked with the business owner & technical team to coordinate the writing, reviewing and approving of Business, Functional and User Requirements, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms Gap Analysis, SOP s, Configuration Spec. I was involved in developing the test approach, performed System analysis and implementation all relating to the validation effort for Watson LIMS v7.3 that was used as a clinical and nonclinical R&D system. The intended use of this application was for creating/designing (PK), (TK) and (PD) studies & to facilitate the tracking, analysis and submissions of clinical and nonclinical study samples in accordance with GLP practices to detect an antibody or antigen in a sample and in accordance with ICH M2 EWG for submissions. Managed the validation effort of Documentum, delta with regulatory/compliance issues involving, GCP, GLP, cGMPs, ICH, and 21CFR Part 11 and was involved in creating Change Requests and Change Control process. Created logical level data models, developed and managed data to be utilized for UAT test cases, performed internal & external audits and worked with SME"s to document labeling and packaging requirements for product samples. Managed the Quality Assurance of various documentation, testing and training programs. Achieved validation and production approval on the electronic Trial Master File (eTMF) system used to facilitate the management of regulated digital clinical trial content, images, classification and retention of BioPharma Clinical Trials and was involved in facilitating an electronic means of archiving paper-based clinical documents through the use of SharePoint & DocComposer v2.4 to be used as the scanning and indexing tool and Documentum used as the repository for the clinical documents.BRISTOL MYERS SQUIBB CORPORATION, New Brunswick, New Jersey 7-08 to 5-09Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant) Developed test approaches, documented business workflow processes and translated business requirements into detailed technical requirements. Created User Stories, Acceptance Criteria's, performed internal and external audits. Worked as the key liaison between the business owner & technical team to manage and coordinate the writing, reviewing and approving of Business, Functional and User Requirements, Val Plan, IQ, OQ, & PQ Test Scripts, testing, resolving issues, Change Requests, Gap Analysis, Risk Assessments, SOP s, Configuration and was involved in the Implementation and Application Support process all relating to the validation effort involving Maximo, LIMS Sample Manager, Labware LIMS, Labware ELN, TrackWise, Learning Management System LMS, PLM a Product data platform, SAP, Product Lifecycle Data Management (PLM) module, Environmental Health & Safety (EHS), SAP Manufacturing, Master Data (MD), Quality Management (QM) module involving integrated components such as the MM, PP, PM, SD, FI, and Solution Manager module. Defined business objectives, resolved testing issues, authored SOP s related to Maximo, LIMS, TrackWise, SAP, reviewed and approved change requests and delta with regulatory/compliance requirement issues involving e-Pedigree and International Serialization regulations, H.R. 3204, GCP, GLP, cGMPs, GMAP5, ICH, ASTM E2500, 21CFR Part 11, IBM WODM (iLog Jrules) and SOX and performed internal and external audits. Managed the Quality Assurance of various documentation, testing and training programs. Supported Business Systems in a manufacturing, planning and supply chain role for the Material group. Worked closely with cross-functional teams to identify opportunities for improvement through system or other data sources to improve bills of materials, manufacturing specifications, reporting. routing and business processes. Created project plans, standard work instructions, conduct group training for new processes and was involved in build analysis models/reports for standard business tasks. Reviewed and approved all documentation in Documentum and the software tools I used for this effort were BluePrint and HP Quality Center.ICON CLINICAL RESEARCH, North Wales, PA 10-07 to 7-08SQA Engineer Level III Manager (Consultant) Created and modified BDR, FRS & URS requirements in BluePrint, developed testing strategies, UAT testing, writing IQ, OQ, PQ scripts, RTM and provided guidance to offshore script writers, testers and Medical Affairs. Reviewed and approved all documentation in Documentum. Documented business workflow processes, created and updated Validation Plans, System Test Protocol Plans, Configuration Specifications, UAT Plans, Summary Reports, SOP s, pre & post approval of scripts, provided guidance on regulatory issues, SDLC, validation, compliance and 21 CFR PART 11 and training as needed. Performed Risk Assessments, Audits, Testing, Configuration and Implementation and provided Application Support, all relating to the validation effort of ARISg & Argus and help managed both projects. Recommended to use the SDLC risk base approach/methodology and follow GAMP4 practices to archive production approval of the Adverse Reaction Information System Global (ARISg) & Argus a Pharmacovigilance Safety System primarily used to track, process, and report on Adverse Events and Serious Adverse Events (SAE s) involving clinical trials, drugs, medical devices, data entry support for drugs, vaccines, biologics, devices, literature and clinical trial reports. Both provided a case handling/workflow module allowing users to route cases automatically placing them in their appropriate workflow based on the company s business rules enabling users to track who was responsible for specific actions and provided adverse event reporting for MedWatch, CIOMS, BfArM, CERFA, MHRA spontaneous, and for clinical reports. Experience with Argus safety database and PV Operations, including configuration, reporting, support and maintenance. The application determined reporting responsibilities, timelines, and supported electronic reporting involving the export of E2B files that would be transmitted to regulatory agencies in compliance with international safety reporting regulations and 21 CFR Parts 11 803 and 806.BRISTOL MYERS SQUIBB CORPORATION, New Brunswick, New Jersey 4-07 to 9-07Validation Specialist (Consultant) Developed test approaches, translated business requirements into detailed technical requirements, worked as the key liaison between the business owner and technical team and performed internal and external audits and I help manage the validation effort. Coordinated the writing, reviewing and approving of Business, Functional and User Requirements, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports. I was involved in resolving issues, testing, writing and approving Change Requests, Gap Analysis, Risk Assessments, SOP s, Configuration, Implementation and Application Support all relating to the validation effort involving Maximo a CMMS designed to maintain a centralized history of work orders, scheduling, inventory, preventive maintenance, compliance and cost info involving equipment & maintenance activities, Learning Management System (LMS), TrackWise a quality/compliance CAPA application, LIMS Sample Manager a clinical R&D system designed to QC, receive, handle & authorize sample results, check stability of sample, run/produce reports, PLM a Product data platform, SAP Product Lifecycle Management (PLM) module, Environmental Health & Safety (EHS) module, Master Data (MD) module, Quality Management (QM) SAP Manufacturing, module involving integrated components such as the MM, PP, PP, PM, SD, FI and Solution Manager Module and SharePoint Records & Document Management System. Dealt with resolving regulatory/compliance issues involving e-Pedigree and International Serialization regulations, H.R. 3204, GCP, GLP, GMAP5, 21CFR Part 11 and SOX and worked with software tools HP Quality Center and BluePrint and reviewed and approved all documentation in Documentum.JANSSEN PHARMACEUTICAL, Titusville, New Jersey 2-06 to 3-07QA / Validation Manager (Consultant) Managed the QA/Validation department which involved managing and overseeing the Validation, Implementation, reviewing and approving of validation and training documentation, management of CAPAs, managing the development/revision and reviews of various forms and templates related to CRMS, supported internal audits. resolved project and testing issues and performed testing of software and hardware on various projects involving the SAP QM, MD and Financial module and Siebel 7.8 a CRMS application which involved Sales Force Automation (SFA), Managed Marks (MM), Territorial Management (MM) and Customer Call Center (CCC) interfaces and worked on their LMS system. Managed various personnel such as the QA Lead, Validation Specialist and Business Analyst that were assigned to the Seibel, SAP and D2L projects. Help create logical level data models and develop and managed data to be utilized for UAT test cases.
Worked with the business owner on Business Requirements, Test Scripts, Test Protocol Plans, Val Plans, Summary Reports, forms, related SOP s for SOX deliverables, Business Process/Workflow SOP s, Document Control Matrices, reviewing of pre and post testing documentation and ensured all software/hardware documentation and testing was compliant with 21CFR Part11, GxP, HIPAA, PDMA, SOX and SDLC and ITIL methodologies. Performed internal and external audits and handled regulatory/compliance issues, Provided testing, validation, application support and training for D2L a LMS application and Siebel 7.8 a CRM application for Sales Force Automation (SFA), Managed Marks (MM), Territorial Management (TM) and Customer Call Center (CCC) interfaces. Coordinated the activities of determining, gathering and documenting new requirements, workflows and processes and provided compliance and regulatory training as needed. Reviewed and approved Change Control Requests and documentation involving Project Plans, Quality Plans, Validation Plans, System & Integration Data Conversion Plans, Test Protocol Plans, URS s, FRS s and SDS s etc. Supported Business Systems. Worked closely with cross-functional teams to identify opportunities for improvement through system and other data sources to improve bills of materials, manufacturing specifications, reporting. routing and business processes. Created project plans, standard work instructions, conducted group training for new processes and was involved in build analysis models/reports for standard business tasks. Performed Risk and Vendor Assessments, managed the testing and validation per J&J validation requirement (QSP6014) and per the SDLC process to ensure proper planning, impact analysis, development, and proper testing was performed before deploying new system software into a production environment and performed internal and external audits.
Carried out dry runs to help develop the system and weed out possible defects and changes that might be needed to satisfy workflow needs and functional, user and business requirements before formal testing. Collaborated with Skura a vendor used to support the testing, operation, development and integration effort. Managed and monitored the day-to-day actives of various projects through HP Quality Center that involved reviewing and approving unit, system, integration and UAT testing. Reviewed and approved all documentation in Documentum and this effort involved using testing tools such as: HP Quality Center, Quick Test Pro and LoadRunner.SYSTECH INTERNATIONAL, Cranbury, New Jersey 6-04 to 1-06SQA Manager / Documentation Manager Managed the SQA, validation and documentation department which involved testing and validation of software releases and testing/validation activities (creating, updating and executing IQ, OQ, & PQ test scripts, system and UAT testing and document control tasks such as; reviewing and approving Change Requests, assigning & controlling part and document numbers, and revision levels). Created, updated, reviewed & approved various SDLC/validation documentation consisting of Test Plans, Validation Plans, FAT s SAT s, UAT Plans, Configuration Specifications, BDR s, SDS s, FRS s, URS s, and Operation and Assembly Manuals all relating to the design, manufacturing and functionality of the Inspection/Vision Solution Systems. The Inspection/Vision Solution System was primarily used for product, packaging and labeling line inspections relating to Manufacturing Execution Systems (MES) in the pharmaceutical industry. Supported the creation of various training documentation. Ensured training plans were updated in our Learning Management System, was involved in the management of CAPAs, and managed the development/revision and reviews of various templates used |
