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PwC brand, Mumbai metro location, and mid-level title increase competition despite CSV niche.
Role requires GxP, FDA and CSV domain expertise, limiting cross-industry transferability.
Explicit 4–12 years, mandatory CSV/GxP knowledge and validation deliverables imply high filtering.
Own the execution of Computer System Validation (CSV) activities including authoring validation deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Conduct manual testing (positive, negative, regression, smoke, sanity) and defect tracking as per SDLC/STLC methodologies (Waterfall, Agile, V model CSV).
Ensure adherence to regulatory guidelines like GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11 and manage compliance processes including Change Control, Deviation Management, CAPA, and Periodic Review.
4 to 12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Engineering or Bachelor of Technology degree mandatory.
Knowledge and experience in SDLC methodologies (Waterfall, Agile) and CSV V model.
Familiarity with GAMP5 Guideline, GxP regulations, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and manual testing techniques.
Candidate experienced in end-to-end CSV lifecycle and manual testing in regulated environments such as pharma or life sciences.
Comfortable working with multiple methodologies including Waterfall, Agile, and V model, with strong documentation and compliance skills.
Familiarity with CSV tools like Valgenesis and experience in related systems like LIMS/QMS is preferred but not mandatory.