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Strong PwC brand and Mumbai location increase applicant density, while CSV/GxP specialization reduces it.
High due to specialized CSV, GxP regulatory and internal audit experience, limiting cross-industry transferability.
10+ years, mandatory CSV/GxP experience and specific validation deliverables make shortlisting highly stringent.
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Own and execute Computer System Validation (CSV) processes for clients, including authoring and reviewing validation documentation such as Validation Plans, URS, FRS, and IQ/OQ/PQ protocols.
Apply expertise in CSV tools (preferably Valgenesis) and methodologies including Waterfall, Agile, and V model to ensure compliance with GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Lead software testing activities encompassing manual testing types (positive/negative, regression, smoke, sanity) and defect management, supporting risk assessments and compliance controls in IT environments.
8-12 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance, total work experience preferably 10+ years.
Educational qualification: Bachelor's degree mandatory (B.Tech required, M.Sc or B.Pharm also acceptable).
Mandatory knowledge of GAMP5, GxP regulations, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Experience authoring key CSV deliverables including Validation Plans, URS, FRS, Functional Risk Assessment (FRA) using FMEA, Design Specifications, IQ/OQ/PQ protocols, and Validation Summary Reports.
Experienced Manager or Senior Professional with deep domain knowledge in CSV within regulated industries, accustomed to managing end-to-end validation and compliance documentation.
Familiar with structured SDLC and STLC methodologies, with hands-on experience in manual software testing techniques and defect tracking.
Able to work in Agile and Waterfall environments, leveraging both technical and regulatory expertise to guide audit and compliance initiatives effectively.