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PwC brand and metro location increase applicant density, but specialized CSV/GxP skillset limits broad competition.
CSV and GxP regulatory expertise is industry-specific, limiting cross-industry transferability.
Explicit 4–8 years requirement and mandatory CSV/GxP certifications make filters strict.
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Own and execute Computer System Validation (CSV) activities including authoring validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, FRA using FMEA, DS, IQ/OQ/PQ protocols, and Validation Summary Report.
Perform software testing including manual testing techniques (Positive/Negative, Regression, Smoke, Sanity), defect tracking and reporting following SDLC and STLC in Waterfall, Agile, and V model methodologies.
Ensure compliance with regulatory requirements (GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+) and manage Change Control, Deviation Management, CAPA, and Periodic Review processes.
4 to 8 years of work experience in Computer System Validation, Software Testing, and IT Compliance.
Educational qualification: M.Pharm / M.Sc / B.Tech / Master of Engineering / Bachelor of Engineering.
Mandatory skills: Computer System Validation (CSV).
Knowledge of regulatory guidelines (GAMP5, US FDA 21 CFR Part 11, EU Annex 11) and validation principles (ALCOA+).
Experience with manual software testing and defect management within regulated environments following SDLC and STLC.
Demonstrated ability to author detailed CSV documentation and understand risk assessment techniques like FMEA.
Familiarity with CSV tools (preferably Valgenesis) and optional knowledge of LIMS/QMS for enhanced compliance management.