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Click here or scroll down to respond to this candidateCandidate's Name
Parsippany, NJ Street Address
PHONE NUMBER AVAILABLE EMAIL AVAILABLESUMMARYTechnical analysis,EHS audit,PFDs,P&IDs,CAPA,KPI,clinical data management,clinical trial.Regulatory compliance,QC/QA,audits,cGMP,GLP,GCP,GDP,GxP,document change management process in CelDox,veeva,novastyle,NJ-EHS-regulated medical waste,PV,Updating SOP's and control specifications.Medical device risk management per ISO PHONE NUMBER AVAILABLE,EUMDR,EMA,design failure mode and effect analysis.Good documentation practices standard,global quality system manual, regulatory inspection readiness,records Management,identifying data integrity deviations,TSCA,best practice,punch list,SAP database.Transfer of analytical test methods,validation of cell-based methods for cell therapy development,corporate Adverse event reporting policy,global reproductive health and safety,assay control,standard operating Procedure,batch records review,TrackWise,QA lot disposition,MACSQuant flow cytometer.PROFESSIONAL EXPERIENCEBristol-Myers Squibb,Summit West,NJ May 2019 to Jan 2024Senior QA/Regulatory Affairs ComplianceProvide training solutions to the site training program,GMP training,quality systems organization.Intermediate skills in design,development and implementation of training to navigate a document management system (DMS) and learning management system (LMS).Suggest process improvements for quality and safety of the product by reducing errors and defects,adapt regulations,Improving employee training and implementing CAPA.Properly communicate e-mails and routine business matters with management with high level of accuracy, demonstrate basic writing skills and be able to follow technical reports.Preparing document packages(Regulatory Dossier) for regulatory submissions demonstrate a product s safety,quality, and efficacy to regulatory authorities to ensure compliance with regulations.Strong technical writing skills for authoring and revising of high-quality GMP documentation in support of quality operations at the Summit cell therapy manufacturing facility,in accordance with celgene policies,standards,procedures and global cGMP includes,but not limited to,SOPs,work instructions,reports and technical documents.Support of dispositioning product for compliance with client directives,procedures and regulatory standards.Responsible for quality expertise and oversight of the batch disposition process to deliver high-quality documentation as per FDA and ICH guidelines in highlight regulated environment and to follow GDPs.Collaboratively work with manufacturing and cross-functional stakeholders to ensure deliverables are met to support disposition and perform compilation and review of batch release documentation packages.Work independently and within cross-functionally teams and act as SME during external audit/inspections.Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.Prepares,revises,routes,reviews and approves GMP documents in support of quality assurance cell therapy Operations using strong organizational skills and critical thinking skills.Works with teams to obtain in-depth understanding of QA processes and their documentation requirements.Produces and reviews high-quality documents that meet applicable standards and are appropriate for their intended audience as per FDA/EMA regulatory requirements applicable to biologics,pharmaceuticals.Work in a highly regulated environment to follow GDP,GMP electronic documentation systems.Work in a collaborative team environment,train others,mentor associates and set priorities for the group.Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.Strong organizational skills and critical thinking skills helps authors and revises GMP documents.Authoring new documents for GMP test execution,equipment training,sample management and software.Managing the development of documents through EDMS for the execution of change controls as needed.Knowledge of regulatory submissions of series of documents to a health authority as evidence of compliance.Authored non-validation protocols,validation summary reports,parameter analysis and SOPs for deviations in Veeva,also perform each run s QC data package can be scanned and verified.Worked closely with manufacturing and QC team to perform root cause analysis for product specifications.Access the source system during HA inspections,internal audits,data integrity check,data governance.Follow guidelines of CDER(center for drug evaluation and research),MHRA(medicines and health care products Regulatory agency),FDA,EMA(european medicine agency),GVP(good PV practice)for european union, also good practice for data management and Integrity in regulated GMP/GDP environment.Novartis,EastHanover,NJ Jan 2019 to May 2019 Senior Technical Writer(QA/Regulatory),Cell&GeneTherapyTo set up the governing documentation for the pilot plant in cell & gene therapy.Knowledge of SDLC,system design,development and validation for regulatory requirements.Responsible for standards and GXP,CV (IQ/OQ,PQ),regulatory compliance 21 CFR Part 11,CFR 820,Part 1271,Part 211,29 CFR 1904,29 CFR 1910,ISO13485,14001,9000,9001 to meet the requirements of regulatory as per IT-pharma medical device quality and compliance.Assists analytical and process science on authoring developmental protocols and reports.Co-ordination of timelines,document revisions and review cycles for all GMP documents.Manage validation projects within regulated environment,understanding of 21 CFR Part 11.FDA GXP requirements and computer system validation documentation with GDP.Review of completed batch records and other GxP documents in collaboration with QA as needed to ensure accuracy and completion in accordance with cGMP regulations.Supports preparing qualification master plans,risk and impact assessments,protocols and summary reports and co-ordinates review and approvals of the documents.Authors,reviews,updates and assists in developing departmental SOPs and qualification documents/programs, also Identify and anticipate risk of non-compliance and address them.Analyze QMS metrics and develop recommendations for improvements to the management.Ensures that all activities are in compliance with cGMP,HA regulations and the client policies.Bellerophon Therapeutics,NorthBrunswick,NJ Aug 2018 to Jan 2019Lead Regulatory SpecialistMember of professional team for commercial deployment of the iNO pulse delivery system of current clinical trials and responsible for Mark-2 device evaluation,calibration,compliance log,testing.Knowledge of lean six sigma,continuous process improvement throughout the enterprise.Follow international regulations like code of federal regulations(CFR), european union medical device (EU MDR), quality system regulation(QSR), quality management system for medical device (ISO 13485), medical device single audit program(MDSAP) and pharmaceuticals and medical devices agency(PMDA),international medical device regulators forum(IMDRF).Possess experience working in pharma industry in a regulated IT environment with complete drug life cycle Process,ranging from drug discovery,clinical trials,manufacturing to pharma sales and marketing.Perform laboratory activities,deployment of high quality,reliability drug delivery system helps medical device verification to follow FDA,risk management,QMS,continuous improvement,regulatory compliance.Processing medical device return,servicing,technical evaluations and verification technical activities.Responsible for ISO 13485 for quality management system for medical device.Ensure consistent quality throuout a medical device lifecycle from design to disposal for patient safety.Work with QMS software QT9 (Automating ISO requirements)ISO compliance,ERP,manufacturing management software,integration quality integration,ASL 5000 breathing simulator,INGAR medical simulation script editor,lab Chart version 8 by AD instruments,service control module revision 985.Involved in analysis of linear regression of the flow volume and reporting of slope and intercept an error.Becton Dickinson,FranklinLakes,NJ March 2017 to June 2018Regulatory Affairs SpecialistKnowledge of design control and working with Instron tensile tester with blue hill 3.Perform testing for leakage past stopper to meet ISO7886:1,1993 AnnexD and IQ,OQ,PQ for infusion pumps.Reading and understanding assembly drawings,manufacturing,test instructions and service manuals.Involved in Regulatory Submission process to demonstrate product s safety,efficacy and quality,Knowledge of all phases of SDLC/CSV lifecycle for enterprise system applications including agile validation methodologies in scrum environments and client specific methodologies,assist in product and prototype testing.Document test results and communicate with R&D engineers as required,strong technical writing skills for project and regulatory documentation,also participate in gauge R&R studies.Knowledge of EUMDR,EMA regulation to govern the production,distribution and clinical investigation of medical devices.Handling customer complaint reportsina timely manner and in compliance with FDA regulations, interacting with regulatory agencies, and recommending corrective actions for non-conformities.Collaborate with cross-functional teams, train other departments, and support the development of process and product protocols as well as other jobs assigned when needed.Follow guidelines of American Society for quality (ASQ) to improve the quality of medical device .Provides feedback to medication and procedural solutions (M&PS) research and development,advanced product Development services (APDS),knowledge on testing software,firmware and hardware by test protocols.Play a critical role in supporting the group s efforts with respect to medical device testing product for design verification and shelf life,test method validation summary report.Supports all product development and product engineering platforms across MPS,help the team by way of expertise and efficiency in a variety of mechanical,physical and electronic testing of medical device products.Contribute to the improvement of existing testing methodologies,measurement system development and analysis of test methods,competitive analysis,test performed by following test protocol or test instruction.Suggest based on corrective actions if any changes in process,procedures,resources,quality policy,objectives,works instructions or controls.Responsible for the testing will help products to meet customer s expectations and regulatory requirements.Product development processes,regulatory,quality requirements and design controls,such as 21 CFR 820.30.Test consists cleaning a medical device using different disinfecting wipes will be used to evaluate and determine performance after completing the required disinfecting cleaning cycles.Responsible for ISO 13485 for quality management system for medical device.Ensure consistent quality throuout a medical device lifecycle from design to disposal for patient safety.A functional verification will be performed connecting the device to established communication with software.Perform measurement system analysis for different products and testing for other medical device.Bureau Veritas,Linden,NJ Oct 2016 to Feb 2017Laboratory QA Inspections SupervisorOperates laboratory equipment and instruments such as microscopes,centrifuge,agitators,viscometer,chemical balance scales,spectrophotometer,gas chromatograph,colorimeter and other equipments.Maintaining a GMP and GLP environment,including equipment maintenance and calibration management.Test materials for presence and content of elements or substances such as hydrocarbons by ASTM methods.Proficiency in documenting results according to good documentation practice standards.Prepares graphs and charts and calibrates laboratory instruments.ExxonMobil,Clinton,NJ May 2015 to Nov 2015Research EngineerCoordinates and develops with analytical,process science, engineering and QA team qualification projects and plans identifies the critical to quality parameters impacting qualification activitiesAnalytical skills to determine quality and reliability improvements based on laboratory results.Responsible for careful,deliberate,disciplined,meticulous and well organized in performing laboratory testing and recording results,follow GHS of classification,labeling chemicals,SDS,EHS label creation,near misses.As per OSHA regulation updated data in share point for the new chemicals SDS,order shipment review and release,compliance with all federal,state and local regulations,implements policies and procedures,knowledge of EPA and DEA,calibration of analytical instruments.Qatar Energy,Qatar May 2009 to Dec 2014Operation Engineer Field Development-ProjectsQatar Energy,a billion-dollar energy utility into electric and gas systems and energy efficiency.Familiarity with ASME,API and NFPA,IDLH,SCBA,NIOSH,FEED,EPIC,FS,SOW,SOR,PCR,MCC,TOC,ACC, Fire,safety,ISO 9001,ISO 14001,confined space permit,hot /cold work permit.Used maximo and continuous improve equipment preventative and corrective maintenance.Participate for process related matters,reviewing PCR for approval/rejection and carrying out PCR detail engineering and making ipmplementation,SOR evaluation,recommendation and final approval as a focal point.Review and approve all permanent process trip setting,change requests to meet operation requirements,review, update documentation and drawing on periodical basis.Process design and documentation of activities throughout project lifecycle to meet milestones to maintain KPI.Reliance Industries Limited,India Aug 1989 to May 2009 Senior Process ManagerResponsible for the start-up,validation and operation of a new manufacturing facility.Manage external or internal technical transfer activities and lead the implementation of new cGMP processes, equipment and materials,manage complex troubleshooting and problem-solving efforts.Integrate safety,compliance and quality systems into manufacturing operations and ways of working.Determine manufacturing KPIs,establish tools to monitor and report metrics and implement actions.Perform and oversee process unit operations described in SOP and batch records.Complete and review documentation for process transfer protocols,validation protocols,SOP and BR.Ensure the shift performs tasks in a manner consistent with the safety policies,quality systems.Lead deviation investigations and support on-time closure of deviations and CAPAs.Work with production planning,process improvements and area management to establish daily unit operations schedule that includes people,product and material flow across multiple shifts.Indo-Nippon Chemical Limited,India May 1988 to Aug 1989Senior ChemistWork as senior chemist for the Laboratory testing and analysis to direct the plant batch as per the test results.Responsible for analysis of shore e hardness,tensile strength,color as per american public health association.Set up R&D reaction with different composition on small scale for different plasticizers.Education:Bachelor of Science,Chemistry : Maharaja Sayajirao University of Vadodara (India),1988. |
