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PwC brand, mid-level experience and Mumbai location increase competition, but specialized CSV/GxP skills moderate it.
Highly domain-specific CSV, GxP and regulatory validation expertise limits cross-industry transferability.
Explicit 4–8 years CSV requirement plus mandatory GxP/21CFR/GAMP5 knowledge makes shortlisting strict.
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Own and execute Computer System Validation (CSV) activities including creation of validation deliverables such as Validation Plans, User Requirements Specifications, Functional Requirements, and Validation Summary Reports.
Conduct manual software testing covering various testing types (positive, negative, regression, smoke, sanity) within SDLC and STLC frameworks using models like Waterfall, Agile, and V model of CSV.
Ensure compliance with regulatory requirements including GAMP5, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and manage related processes like Change Control, Deviation Management, CAPA, and Periodic Review.
4-8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Engineering degree; B.Pharm education also mentioned (ambiguous but BE required).
Mandatory skills: Computer System Validation (CSV).
Knowledge of regulatory standards such as GAMP5, US FDA 21 CFR Part 11, EU Annex 11, ALCOA+ principles required.
Experienced in manual software testing and defect tracking within various SDLC methodologies including Waterfall, Agile, and V model specific to CSV.
Familiarity with CSV tools such as Valgenesis and additional domain knowledge in LIMS/QMS is preferred.
Capable of authoring and managing detailed validation documentation and risk assessments (FMEA) complying with strict regulatory frameworks in pharmaceutical or related industries.