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Tier-1 brand and metro location increase competition, but niche CSV/GxP skills limit candidate pool.
Highly regulated CSV/GxP/FDA focus limits cross-industry transferability.
Explicit 4–12 years plus mandatory CSV/GxP/FDA expertise enforces strict shortlisting.
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Accountable for 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 software testing (positive/negative, regression, smoke, sanity), defect tracking, and ensure compliance to GxP regulations and US FDA 21 CFR Part 11.
Apply knowledge of SDLC (Waterfall, Agile) and STLC, while managing Change Control, Deviation Management, CAPA, and Periodic Review processes.
4 to 12 years of professional experience in Computer System Validation, Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree mandatory.
Knowledge of GAMP5 guidelines, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and compliance frameworks.
Experience with CSV deliverables and manual testing methodologies; preferred exposure to CSV tools like Valgenesis.
Experienced professional with robust background in CSV within regulated environments such as pharmaceuticals or life sciences.
Familiarity with SDLC methodologies (Waterfall, Agile) and CSV V-model, capable of handling end-to-end validation and compliance documentation.
Comfortable working in advisory or internal audit settings focusing on IT compliance and risk management.