(Ref:BM) CSV Team member - Contract (Work from Office Ahmedabad)
SaaVidya and ruralGCC · Ahmedabad · onsite · Posted 58d ago
Not disclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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.
Benefits
Contract
Period: 6-12 months
Location: Work from Office Ahmedabad
- 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.
Benefits
Contract
Period: 6-12 months
Location: Work from Office Ahmedabad
Sourced from foundit
Skills
testing executiondata integritydocument signoffsUATURSAudit ReadinessPQIQrisk assessmentsfsTest scriptsDefect managementOQHypercare SupportsitSystem ValidationValidation Plansvalidation strategycompliance reviewsImplementationsTraceability MatrixGxP regulationsvalidation summary reportsRegulatory ComplianceFDA requirementsgo-live readiness