Please do respond to rahul.agarwal@tresourceinc.com
Job Title : Validation Engineer
Location : Ann Arbor, MI
Duration : 12+ months Contract
Job Description:
• 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.
Kindly share all these details, I need to submit your profile..
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Thanks and Regards,
Vineet Aggarwal
Technical Recruiter
Technology Resource Group Inc.
3736 Hills-dale Court, Santa Clara, CA 95051
Contact : 408-709-1760 (EXT-674)
Mail To: vineet@tresourceinc.com | www.tresourceinc.com
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