Job Description - (Ref:BM) CSV Team member - Contract (Work from Office Ahmedabad)
- 8+ years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
- Strong knowledge of GxP regulations, FDA requirements, and industry compliance standards governing validated systems.
- Proven experience in preparing, reviewing, and approving validation deliverables, including Validation Plans, Risk Assessments, URS, FS, Traceability Matrix, Test Scripts, IQ/OQ/PQ, SIT, UAT, and Validation Summary Reports.
- Expertise in ensuring regulatory compliance, audit readiness, data integrity, and system validation throughout the project lifecycle.
- Capable of supporting validation strategy, testing execution, compliance reviews, defect management, document signoffs, go-live readiness, and hyper care support for SAP implementations in a regulated environment.
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