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Tier-1 brand and Mumbai metro increase competition, but niche CSV/GxP specialization reduces applicant density.
Role requires domain-specific GxP, 21 CFR and CSV expertise, limiting cross-industry transferability.
Mandatory 10+ years and specific CSV/GxP/FDA validation deliverables create stringent screening filters.
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Own and execute Computer System Validation (CSV) activities including authoring deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Manage CSV processes in adherence to GAMP5, GxP, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles with change control, deviation management, CAPA, and periodic review.
Perform manual testing activities (positive/negative testing, regression, smoke, sanity) and defect tracking within SDLC and SDLC methodologies like Waterfall, Agile, and V-model.
10+ years of work experience in Computer System Validation (CSV).
Knowledge and experience in GAMP5, GxP regulations, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Familiarity with Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC), including manual testing types and defect tracking.
Education: B.Pharm/M.Pharm/B.Tech or equivalent degree.
Experienced in delivering CSV in regulated environments, preferably with exposure to CSV tools like Valgenesis.
Strong understanding of risk assessment methods such as FMEA and operational experience in authoring key CSV documents.
Comfortable working with complex compliance requirements in life sciences or pharmaceutical sectors.