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Tier-1 employer and metro location increase competition, but niche CSV/GxP specialization limits applicant pool.
Niche CSV, GxP and FDA compliance requirements make skills less transferable across industries.
Explicit 4-8 years and mandatory CSV/GxP/FDA skills create strict screening filters.
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Own and execute Computer System Validation (CSV) activities including authoring CSV deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Perform manual testing (positive, negative, regression, smoke, sanity tests) and defect tracking adhering to SDLC/ STLC methodologies such as Waterfall, Agile, and V-Model specifically in a GxP regulated environment.
Ensure compliance with regulatory standards including GAMP5, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles, and manage change control, deviation management, CAPA, and periodic reviews.
4 to 8 years of work experience in Computer System Validation, Software Testing, and IT Compliance.
Educational qualification: M.Pharm, M.Sc, or B.Tech in Engineering (Master or Bachelor level, preferably in Engineering).
Knowledge of GAMP5, GxP regulations, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles is mandatory.
Experience with manual testing, defect tracking, and authoring CSV deliverables is required. Preferred exposure to CSV tools like Valgenesis.
Has a strong background in regulated environments involving Computer System Validation and IT compliance with deep familiarity of CSV lifecycle documentation and regulatory prerequisites.
Experienced in working with various SDLC methodologies including Agile and Waterfall and applying manual testing techniques within a quality-driven context.
Demonstrates capability to manage compliance as per FDA and EU regulations and to handle deviation, CAPA, and change management processes effectively.