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PwC brand and Mumbai location increase interest, but CSV regulatory specialization reduces candidate pool.
Specialized CSV and GxP regulatory expertise limits cross-industry transferability.
Mandatory 4–8 years, CSV expertise, and regulatory qualifications enforce strict candidate filters.
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Accountable for Computer System Validation (CSV) activities including authoring deliverables such as Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Validation Summary Reports.
Perform and oversee manual testing (positive, negative, regression, smoke, sanity) and defect tracking within SDLC and STLC frameworks following Waterfall, Agile, and V-model methodologies.
Ensure compliance with regulatory guidelines such as GAMP5, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles, including managing Change Control, Deviations, CAPA, and Periodic Review processes.
4-8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor's degree in Pharmacy (B.Pharm) or Engineering (Bachelor of Engineering).
Knowledge of CSV tools such as Valgenesis preferred.
Mandatory skills: Computer System Validation (CSV); knowledge of GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11.
Experience working within regulated environments requiring compliance with GxP and FDA regulatory guidelines, indicating familiarity with pharma or life sciences validation.
Demonstrates strong expertise in manual testing techniques and defect management within SDLC and STLC frameworks.
Comfortable authoring complex validation documentation and working with cross-functional teams to ensure audit readiness and quality compliance.