SQA - CSV Validation Engineer - Princeton, NJ (Need Locals / Onsite) at Princeton, New Jersey, USA |
Email: [email protected] |
Role: SQA CSV Validation Engineer Location: Princeton, NJ ( Need Locals / Onsite) Duration: 12+ Months Job Description: Experience in Tealium JavaScript and React experience. Experience in Tagging on a website Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation Requirement Specification document review and approvals System Implementation Plan Review System Implementation Summary Report Review Review and Pre-Approve ST/UAT Test Scripts in ALM Create, Update RRA (Regulatory Risk Assessment) and obtain approvals Post Execution Review and Post Approvals in ALM gR Implementation Approvals Retirement Plan Revew Retirement Summary review Deliverables: Requirement document Validation/Test Plan Requirement Traceability Matrix Change Requests Impact assessment document Test/Validation Summary Report Thanks & Regards Manoj Vemula : [email protected] LinkedIn: linkedin.com/in/manoj-vemula-52a356209 5490 McGinnis Village Place Suite 237 Alpharetta GA 30005 Web : www.nexwaveinc.com USA II INDIA II Canada II UK II Germany Keywords: Georgia New Jersey SQA - CSV Validation Engineer - Princeton, NJ (Need Locals / Onsite) [email protected] |
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Tue Jul 30 20:46:00 UTC 2024 |