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Click here or scroll down to respond to this candidateSrinivas ReddyComputer System Validation and Quality & Compliance(Edison, NJ), PH: PHONE NUMBER AVAILABLESummaryOverall, 24 + years of Pharmaceutical, Manufacturing, Media, and Federal Government, Telecommunications experience in Computer System Validation and Quality & Compliance, and QA Lead.Ability to prioritize, organize, plan, and manage multiple tasks efficiently and having Excellent written and verbal communication skills and strong leadership qualities.Evaluates validation activities and documentation to ensure that they meet FDA standards, and deliverables such as Validation Plan, User Requirements, Test Plan Protocols, Validation Summery report, Risk Assessments Reports, and Traceability Matrix.Experience in generating, reviewing, and executing validation and change control documents, authoring SOPs, Protocols (IQ, OQ, PQ) of Process Control SystemsExpertise in development of QA project deliverables, such as System and UAT design test scripts and System, UAT test protocols, and Summery Report for System and UATExperience in FDA regulations, validation, and GxP, SOX compliance requirements as they relate to the validation protocols and IQ (installation qualification), OQ (Operational Qualification), and PQ (Performance Qualification), related manufacturing equipment.Experience in 21 CFR Part 11 820 Electronic Signatures, Electronic Records, Audit Trail, and medical devices. and GAP analysis remediation plan requirementsGood Exposure in Change Management, Change Control, and Review, Edit and Approve, Review Test scripts, CAPA, GAMP guideline approach.Consult with IT/Business/Quality teams on the periodic review observations and continuously monitor the implementation of the remedial actions for the identified observations.Manage Periodic Reviews, CAPA Compliance and Training Compliance for the Teams across the globe.Experience in the development of Standard Operating Procedures (SOPs)Ability to work on multiple projects in a fast-paced environment.Experience in SDLC Methodology Waterfall, Agile, JIRAExcellent understanding of Ascendant / ASAP methodologies, and other ERPsExcellent communication and inter-personal skills, accustomed to working in a team environment with tight schedules and capable of working efficiently under pressure, manage multiple projects.Technical SkillOperating Systems: Windows 95/98/10/NT/2000/XP, UNIX, MS DOSLanguages: SQL, PL/SQL, C++, ABAP/4, AND XMLDatabases: Oracle 8i /9i, 10g SQL Server 2000, DB2, MS AccessGUI: Developer 2000, (Forms 4.5, Reports 2.5), Visual basic 5.0.ERP: SAP R/3 4.5, 4.6C, ECC 5.0, 6.0 FI, SD, MM, CRM, FSCM, HRScripting: VB Script, 4 Test Language, TSL, UNIX Shell ScriptingBrowsers: Internet Explorer, Netscape, Navigator,Interfaces: ALE, EDI/IDOC, Web Methods, Ariba, Siperian, PrismTools: Test Director, HPQC, Clear Quest, Rational Tool, TrackWise, OTIS, SharePoint, MIDAS, DHCV Tool. CHARM Tool, SNOW ToolEducation:Bachelors degree in computersPG Diploma in Computer Application,Diploma in Client/Server Technology,Legal Status:US CitizenBausch Health March24 to PresentBridgewater, NJCSV Validation and QA LeadBausch Health Companies Inc. is a global, diversified pharmaceutical company whose mission is to improve peoples lives with pharmaceutical products. Bausch develops, manufactures, and markets a broad range of branded and generic pharmaceuticals, over the counter (OTC) products and medical devices.Responsibilities/Deliverables:Author, Review and approve SDLC Validation documentation deliverables such as Validation Plan, Risk Assessment, Validation Summery Report, System Documentation Index (SDI), different stream applications.Ensure compliance with 21 CFR Part 11, 211, 820 requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures, and documentation.Review validation deliverables like User Requirements, Functional Specification, Technical Design Documents, and Traceability Matrix, Summary Reports, Change Controls.Draft, Review equipment qualification pre and post approval test cases such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Review and approval of Minor, Major changes in SNOW. Initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software.Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to s or validation related matters.Review and Approve System and UAT Pre/Post Execution Test Scripts, and approving the Defects in ALM ToolWork with various SMEs to obtain needed information to complete SDLC deliverables; Leads testing efforts by managing pre/post approvals and associated discrepanciesProvided Compliance and deliverables input as and when needed by the project stakeholders.Monitoring systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices moving the organization towards a positive risk management.Works collaboratively with project teams to keep them informed of project status, including any barriersMerck, Branchburg, NJ Jan22 to Feb2024Animal HealthCSV Validation and SAP Release ManagerFor more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A.Through our prescription medicines, vaccines, biologic therapies and animal health products, work with customers and operate in more than 140 countries to deliver innovative health solutions.Responsibilities/Deliverables:Author, SDLC Validation documentation deliverables such as QAP (Quality Assurance Plan), QASR (Quality Assurance Summary Report), DTP (Development Test Plan), DSR (Development Summary Report), ATP (Acceptance Test Plan), ATSR (Acceptance Test Summary Report).Reviewing and routing for approval in DHCV Tool for SDLC document deliverables URS (User Requirements Specification), FS (Functional Specification), CS (Configuration Specification), TS (Technical Specification), and DS (Design Specification)Creating the ChaRM documents for Time Sensitive, Quarterly Releases, and moving the status from In Development 2 status to Requested to QA Import status six according to Demand status.Reviewing the Change in SNOW tool and routing for approval to QA for initiation approval, and once build is completed, the Implementation and SDLC documents approvals completed and routing for Implementation approvals to BU, TU, QA. After complete implementation, routing the Change to close out approval.Conducting the demand Interviews in Interview App tracker for Releases with Demand Coordinators.And checking the process id and Change type and cross checking with Change type matrix.Reviewing the pre/post test cases in ALM, and routing for approvals.Providing Fire Fighter access to the consultants for superuser privileges during the deployment to production systemAll SDLC documents related to change types approved/published in DHCV tool, updating the Interview tracker with SDLC documents IDs in release phase.Attending CRB (Change Review Board) meetings every week for Time Sensitive releases.Supporting the business users while executing UAT test execution, encountered defects.Merck Branchburg, NJ Oct18-Dec21Human HealthSDLC Quality Technical Writer/CSV Validation Lead.Responsibilities/Deliverables:Author SDLC documents (QAP, QASR, Test Plan and Summary Reports)Assist in the completion of the Information Risk, Data Privacy, IT 3rd Party Vendor AssessmentsScheduling a meeting with project team to determine the SDLC deliverables, and inserting the inputs like CI name, GxP, Personal Information, business classification, and system classification into Digital SDLC tool and generating the project related SDLC deliverables.Inserting the parameters like system name, Release version, document type, and document title in Digital SDLC tool and Generating the Document IDs.SDLC documents templates tailoring and providing to the project team to draft the documents.Review the SDLC deliverable documents for completion, Good Documentation Practices, and ApprovalsConduct Quality Gate review meetings at the end of each phase to ensure the 41 controls are met.Review and route for approval in MIDAS Tool for SDLC document deliverables such as URS (User Requirements Specification), FS (Functional Specification), CS (Configuration Specification), TS (Technical Specification), and DS (Design Specification)Review equipment qualification deliverable documents URS, SDS, FAT, SAT, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Review equipment qualification pre and post approval test cases such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Prepare the SDLC document tracker and submit for SDLC assessments.Ensure compliance with 21 CFR Part 11, 211, requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures, and documentation.Support Change Management review in Remedy, and GxP systems supporting document management, change controls, variances/ deviations, CAPAs.Review of SIT/UAT test cases and conduct pre and post approvals in ALM tool.Conducting Quality Gate assessments at the end of each phase, to meet the audit requirements.Author remediation to support corrective/preventative measures for internal assessments.Conducted Periodic Reviews for critical GxP Systems, reviewed user access controls/trainings/active user lists and published the reports, coordinated with IT/Business/Quality teams for defining.Created annual periodic review plan by using a risk-based approach to select the high priority GxP IT systems.Published the approved annual plan to the IT/Business/ stakeholders and ensured the implementation of the plan as per defined timelines.Ortho Clinical Diagnostics, Raritan, NJ Sep15-Sep18Validation QA LeadProject: FoundationOrtho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that evaluate for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.Ortho Clinical Diagnostics (Ortho) is separated from J&J, and the OCD data has been migrated from J&J to OCD Foundation project.Responsibilities/Deliverables:Author, Review and approve SDLC Validation documentation deliverables such as Compliance Plan, Compliance Analysis, Test Plan, Test Scripts, and Compliance Reports different stream applications for OCD Foundation project.Ensure compliance with 21 CFR Part 11, 211, 820 requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures, and documentation.Review validation deliverables like User Requirements, Functional Specification, Technical Design Documents, and Traceability Matrix, Reports make sure that all the J&J needed information was being migrated with the OCD framework and following GAMP/GAMP 5 guidelines.Review and Approve System and UAT Pre/Post Execution Test Scripts, and approving the Defects in RQM ToolGuide IT and Business stakeholders collaboratively with project teams, providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects.Interacted with IT and Business stakeholders on internal OCD global regulations focused on the implementation of Foundation Project and advice on risk-based validation, regulatory gaps, and adherence to internal SOPs.Review and Approve PRT (Production Readiness Testing) scripts in production environment.Review, Edit and Approve change controls forms for normal and emergency changes.Support change control processes for the Quality Operations group, evaluating change control documentation, release mgmt., data changes, testing for compliance and GXP impact.Provided Compliance and deliverables input as and when needed by the manager.Monitoring systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices moving the organization towards a positive risk management.Create and implement training documents like QC Guidelines and Q&C Presentations document for the testing team for global audience.All fundamental components of a Quality Management system documents upload/ housed in OTIS tool.Interacted with offshore teams across the globe to ensure compliance requirements were met during testing phase.GM, Detroit, MI July14 Aug15Role: SAP QA LeadProject: Production SupportGM motors upgraded the system version from the existing version to a higher version and made enhancements to the system for thirty-four countries.After went in to live it was hypercare for one year and the project was production supportResponsibilities/Deliverables:Reviewed Test Scope, Business Requirements, and Business Process Procedures and developed the lean Test plan, Test StrategyPrepared QA effort estimation for phase wise, Development, QA, and PRODGathering the Change Request Business Requirements specification and wrote the Regression Test Strategy.For effective Regression testing conducted meetings for impact analysis along with Developers, Functional Analyst, and Business Analyst to identify Regression Requirements, and Regression Test Scenarios.Pre-Approved Regression and Integration test cases/scenarios uploading in for HP Quality Center/ALM.Reviewed Test scenarios and Test Data to sufficient for cover all the possible test scenarios for Integration, Regression in QA environment.Developed Requirements coverage matrix, developed detailed Regression, Integration test scripts/test cases, and defined expected test cases.Reviewed and approved OTC testing scenarios which were executed in HPQC, OTC process Scenarios like inquiry, quotation, sales order, cash order, rush order, deliveries, transfer orders, post goods issue, billing, and release to accounting.Reviewed and approved defects in HPQCDay-to-day operations with offshore, onshore test team and monitor the timelines and quality of their deliverables.CMS Energy, Jackson, MI Feb12- June14Project: BTSRole: SAP QA LeadConsumers Energy, one of the nations largest combination utilities, provides electric and natural gas service to 6.5 million of Michigans 10 million residents with the help of 7,500 employees. It is upgraded SAP and Non-SAP application, Interfaces.Responsibilities/Deliverables:Reviewed project Scope, Project Plan, Business, Functional, Technical Requirements and Process Design documents, and writing Test Strategy, and phase wise Test PlansResponsible for reviewing and approving of all aspects of testing scenarios including Integration Testing, End to End, and Regression testing, UAT, SAP/Non-SAP projects.Reviewed project documentation to become familiar with the scope and purpose of the project, as well as understanding of the process and functionality being tested.Reviewing and approving pre-approvals and post-approvals of test scripts in HP Quality Center.Conducted defects triage meetings to discuss all open defects and track them to closure and approval.Managed Traceability matrix to ensure that test case coverage meets requirements to ensure 100% test coverage.Managed day-to-day activities and guidance to Testing team on test cases, set test strategies, methodologies, and ongoing coverage (testing priorities, escalation, problem Tacking).Reviewed and approved Change Control Forms to move the transports to Quality Environment, Production EnvironmentWorked with testing resources to drive all testing deliverables to completion.Managed all QA project aspects ensuring that QA is the gatekeeper to the production environment.USDOI, Herndon, VA Aug11- Jan12Role: IV&V LeadProject: FBMSThe US Department of the Interior (DOI) is implementing a Financial and Business Management System (FBMS), integrated suite of software applications that helps the DOI to manage a variety of business functions.Responsibilities/Deliverables:Reviewed the FBMS Approved User Acceptance Test Plan (UAT), which specifies testing overview, testing approach, testing strategy, roles and responsibilities and scope of testing.Verified and Validated requirements traceability and requirements to test cases, and BPPs.Reviewed defects and verified that the defect description, resolutions, and validations are clearly stated.Validated the test cases documentation for completeness and accuracy after the successful completion of a test run.Validated that the test steps are recorded, and actual results coincide with expected results as documented.Participated and provided feedback on Test Readiness Reviews to the IV&V Manager.Performed test witnessing assessments of the testing process in action of testers.Builds daily/weekly reports on testing progress and status communicating to the Manager.Prepared the DEEP DIVE Report submitted to IV&V Project Manager.Executed, Integration, Functional, Regression test scripts and recorded the results and uploaded into CQ (Clear Quest)Participated in the Daily Workstream Review Board (WRB) meeting, which reviews the defects, determine Enhancement vs. Defects, Assign Priority.Forest Laboratories Commack, NY Oct10 July11Project: SFARole: Validation QA AnalystForest Laboratories, Implemented CRM Sales Force Automation (SFA) Application.It is a Sales Representative Mobile device (FRxsell) Application, to manage day to day activities, and Information update includes addresses, affiliations, sales data, shipment records and transfer records.Sales representatives can detail their sales calls, record sample disbursements and capture physician signatures on their mobile device.Associated with planning and performing sales calls, inventory management for samples/voucher, sample and voucher distribution, patient coupons.And signature capture for sample/voucher distribution.Responsibilities/Deliverables:Developed Compliance Plan and Compliance Analysis and Compliance Reports Test Plans, and Architecture Design.Reviewed and executed validation deliverables User Requirements, Test Plan Protocols, Test Summery reports, Procedures, traceability matrix, error/defect reports.Reviewed and approved Test templates which contains Plans, Test Scripts, Test Data, Execution Instructions, Test Description, Process Objectives, Test Script ID for uploaded into the Quality CenterValidated and Verified OQ/PQ Formal, CRF, and 21 CFR Part11 FDA federal guidelines documents, and GxP, Compliances, electronic records, and signatures.Guide IT and Business stakeholders on internal Forest Labs and global regulations focused on the implementation of SFA Application and advise on risk-based validation, regulatory gaps, and adherence to internal SOPs.Validated OQPQ Formal Test Scripts, developed the OQPQ protocol and test summery report.Coordinated with SME, Business Owners, Development team for resolution of Issues, and problems approving the defects.Reviewed Pre-Post approval for the test case documentation for completeness and accuracy after the successful completion of a test run, and followed the GDP(SOP)Verified test steps are recorded and actual results coincide with expected results as documented as per test plan, and followed the GTP (SOP)Verified and Validated requirements traceability and FDS requirements to test cases,Reviewed and approved defects and verified that defect description, resolutions, and validations are clearly stated.USDOI, Herndon, VA July10- Sept10Project: FBMSRole: IV&V/TesterThe US Department of the Interior (DOI) is implementing a Financial and Business Management System (FBMS), integrated suite of software applications that helps the DOI to manage a variety of business functions.Responsibilities/Deliverables:Reviewed the FBMS Approved User Acceptance Test Plan (UAT), which Specify testing overview, testing approach, testing strategy, roles and responsibilities and scope of testing.Verified and Validated requirements traceability and requirements to test cases, and BPPs.Reviewed defects and verify that the Defect description, resolutions, and validations are clearly stated.Complete Formal Assessments Review of the quality/completeness of the FBMSIntegration Test resultsValidated the test cases documentation for completeness and accuracy after the successful completion of a test run.Validated that the test steps are recorded, and actual results coincide with expected results as documented.Participated and provided feedback on Test Readiness Reviews to the IV&V Manager.Performed test witnessing assessments of the testing process in action of testers.Builds daily/weekly reports on testing progress and status informing the Manager.Prepared the DEEP DIVE Report submitted to IV&V Project Manager.Executed, Integration, Functional, Regression test scripts and recorded the results and uploaded into CQ (ClearQuest)Executed UAT functional testing of FI Module, AR Installments, BPP_FB70 Customer Invoice, FBL5N_Customer Line Display, FB08 Reverse Documents,Manually Executed UAT functional testing of FI Module, Charge Card Master Table maintenance transaction, and validated ADMIN users on Charge Cards.Participated in the Daily Workstream Review Board (WRB) meeting, which reviews the defects, determine Enhancement vs. Defects, Assign Priority.Warner Bros, Burbank, CA Oct09- June10Project: CosmosRole: QA LeadWarner Bros. has two leading category distribution units, Domestic Television Distribution(WBDTD), and International Television Distribution (WBITD), together, these entities are responsible for the distribution of Warner Bros., Entertainment and Media.It has thirteen units around the world and uses different legacy systems for Create and Maintain deals.Warner Bros has initiated to implement a single system with SAP CRM IPM 7.0 and ECC 6.0Responsibilities/Deliverables:Prepared test plans, which specify testing overview, scope, testing approach, testing strategy, roles & responsibilities, and scope of testing.Coordination with SME to develop System testing, UAT Testing scenarios.Reviewed Uploaded the Test Cases, Requirements, Test Plan, Test Data in Quality CenterMonitored Test Progress and communicated status and issues to the Manager.Reviewed the Test Cases, Integration End to End Test Scenarios, and completeness of Test results.Assisted Functional Team leads, Technical Team leads in coordination of test activities.Reviewed and approved pre-post approval, Formal testing, and Regression testing.Conducted Defect Meetings, assign prioritization of defects and escalate to Project.Manager, if necessary Responsible for monitoring test matrix and communicating status and issues to the Test ManagerMonitored Entry criteria and Exit criteria is meeting as per the Test PlanJohnson & Johnson June08-Sep09Health Care Systems,Piscataway, NJ.Role: CSV QA AnalystProject: SOM OTCUS Region Order-to-Cash (OTC) is a major Johnson & Johnson strategic initiative to integrate 24 separate transactional systems into a single, regional system for 14 participating Medical Devices & Diagnostics companies in the United States, the initiative will create common processes in the order-to-cash cycle from the time a customer places an order through delivery of the product and final payment.This includes processes and systems used for Accounts Receivable, Order Management, Warehouse Management and Transportation Management.Responsibilities/Deliverables:Develop compliance strategy for Medical Device Regulatory Information management system. Author Compliance Analysis, Compliance Plan, Compliance Reports; provide quality review on all other SDLC deliverables.Reviewed all the Validation deliverables URS, TDS, and FDS ensured documentation consistency across all project deliverables.Create and implement training Plan for project team members.Create and implement training documents like QC Guidelines and Q&C Presentations document for the testing team for global audience.Reviewed and approved Pre and Post Approved System and UAT scripts in HPQCPrepared System and UAT Test Summery Reports routed for wet signatures.Ensured applications were compliant with 21 CFR Part 11 and Part 820Ensured the FS documents reflected the PDD and URS documents content.Reviewed and mapped URS, FDS, and PDD, to Test Scripts Traceability MatrixReviewed the TDRs (Test Defect Report) generated during the System TestingReviewed and approved URS, FRS, Validation Plan along with Pre-approval and Post-approval of IQ/OQ/PQ/UAT test scriptsSupport Change Control and periodic releases like Normal and Emergency changes.Interacted with offshore teams across the globe to ensure requirements were met during testing phase.Ensured System test scripts and UAT scripts were mapped with System Protocol, and UAT protocol.Reviewed Pre-Post approval for the test case documentation for completeness and accuracy after the successful completion of a test run, and followed the GDP(SOP)Avaya, Basking Ridge, NJ Feb08 May08Role: QA LeadProject: EnhancementThe automation feature of billing overdue payment fees has been decommissioned in SAP.Automation will streamline the process of billing late payment fees and bring a consistent experience across Avaya customers.It links to the Avaya goal of Strong Financial Position.Responsibilities/Deliverables:Reviewed existing Business Process Procedures and requirement analysis, Test Plan, Test Scope, and Test strategy, Work plan, Test Environment, Test Design, and Execution of Testing Tools.Created Test Data for Auto Cash functional testing three different payment types (Lockbox, EDI, and Credit Cards)Created new payers with T. Code XD01 and assigned selection rule to the payer in the company code data payments transaction screen.Developed debit memos with T. Code VA01 and tested accounting document show debit to A/R at the payer, credit to Revenue, and credit to sales tax payable.Created txt. file and executed FTP in Unix to simulate receipt of the lockbox file from the Bank.Reviewed all scenarios as per functional requirements selection rule on the customer master. If paid amount matches the invoice, an overpayment clears the invoice residual open (DZ15), and if an underpayment clears the invoice but put residual in open (doc type DZ, Posting Key 06)Reviewed Configured Prototype Creation for Late Payment Fees Dunning Procedures as per business requirements.Reviewed and executed several FB70 invoices for the customer using payment terms of due immediately, evaluated that the Invoices show up on the FBL5 transaction.Reviewed and approved that F.2A program selecting appropriate output report and appropriate Document type DI was posted against the customer record that when execute FBL5.Johnson & Johnson Bridgewater, NJ Dec07- Feb08Role: CSV QA AnalystProject: EnhancementsJ&J was reengineering certain intercompany billing processes to improve efficiencies across its affiliates.This project includes the implementation of limited FI, SD and MM enhancements in SAP Financials and the deployment of new processes.Responsibilities/Deliverables:Develop Compliance Analysis, Compliance Plan, Architecture Design, Test Plan, Test Scripts, and Compliance Reports different stream applications for J&J reengineering intercompany billing enhancements project.Ensure compliance with 21 CFR Part 11 and 820 requirements and predicate GxP standards through integrated quality reviews of all computer system validation processes, procedures, and documentation.Reviewed and approved Validation documents URS, PDDs, FS, Configuration document, TDS for various SAP modules like sales order management, material management, FinanceReviewed and approved System Test Report, UAT Report, and Security ReportReviewed and approved System Testing, UAT Testing protocols.Create and implement training Plan for project team members.Support change control processes for the Quality Operations group, evaluating change control documentation, release mgmt., data changes, testing for compliance and GXP impact.Guided J&J business, technical and testing teams regarding meeting Validation requirementsProvided Compliance and deliverables input as and when needed by the manager.Reviewed Test scripts and deviations of the projects that were maintained within the HP Quality center.Developed PRT (Production Readiness Transaction) document and reviewed test scripts and approved.Prepared Traceability Matrix mapping URS, FRS, and Test Cases.Nestle, Minnetonka, MN Feb06- Nov07Role: CSV QA AnalystProject: Upgrade from 4.6 to 6.0HealthCare Nutrition offers complete nutritional solutions for people with specific Illnesses, disease states or the special challenges of different life stages.Nestle Nutrition strives to offer high quality and great tasting products which provide clinically Proven benefits to those with special nutritional needs.Responsibilities/Deliverables: |
