Req: Validation Engineer @ Ann Arbor, MI Designation/Position Name Validation Engineer Number of Vacancies 1 Client Name TERUMO CARDIOVASCULAR SYSTEMS CORP. Rate : 50/hr c2c Customer Interview Required (Yes/No) Yes Duration of the Project 1 year Job Title Validation Engineer Positions based at Ann Arbor, Michigan
Job Description Additional requirement • Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system), • Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities • Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews • Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems • Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests) • Supports risk assessment and system lifecycle processes such as change control and document management. Positions based at Ann Arbor, Michigan Key word to search *Validation of Computer Systems, GAMP5, 21 CFR Part 820 & 21 CFR Part 11, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ), Validation Master Plan* Job Description 1. Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system) 2. Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities 3. Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews 4 Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems 5 Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests) 6 Supports risk assessment and system lifecycle processes such as change control and document management. Mandatory Skills *FDA regulations 21 CFR Part 11, Part 820 GoodGAMP5 Knowledge * *IQ,OQ,PQ, Validation Master Plan Risk Assessment Good User and Functional Requirements specification Good* -- *Thanks + Regards,* *George,* *347-815-4828, (email is PERFECT way to get quick response),* *G talk / YIM/ Skype**: George.humanresource* <http://www.linkedin.com/pub/george-l/63/557/59b> -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-basis+unsubscr...@googlegroups.com. To post to this group, send email to sap-basis@googlegroups.com. Visit this group at http://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.