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Tier-1 brand, mid-level experience and metro location increase applicant density despite niche CSV specialization.
Role requires specialized CSV/GxP/regulatory experience specific to pharma and regulated industries.
Explicit 4–8 years plus mandated CSV/GxP regulatory deliverables make filters highly rigid.
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Own end-to-end Computer System Validation (CSV) activities including authoring deliverables such as GxP Assessment, Validation Plan, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Conduct manual software testing covering Positive & Negative Testing, Regression, Smoke, Sanity testing, and defect tracking within SDLC and STLC frameworks, including Waterfall, Agile, and V model.
Ensure IT compliance with GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and manage Change Control, Deviation Management, CAPA, and Periodic Reviews.
4 to 8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Educational qualification: M.Pharm, M.Sc, or B.Tech (Bachelor or Master of Engineering).
Experience with SDLC methodologies including Waterfall, Agile, and V model of CSV.
Mandatory skills: Computer System Validation (CSV); Knowledge of GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles.
Experienced professional comfortable operating within regulated environments requiring strict IT compliance and validation processes.
Skilled in both manual software testing and authoring validation documentation aligned with CSV standards and regulatory guidelines.
Familiarity with CSV tools (e.g., Valgenesis) and knowledge of LIMS/QMS systems considered advantageous.