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PwC brand, metro location, and broad 4–12 years range increase competition despite CSV niche.
Role requires niche CSV and GxP regulatory experience, limiting cross-industry transferability.
Mandatory CSV/GxP expertise and explicit 4–12 years requirement make candidate filtering strict.
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Own and execute Computer System Validation (CSV) activities including creation and review of validation deliverables such as Validation Plans, User Requirement Specifications, Functional Requirement Specifications, Risk Assessments, and Validation Summary Reports.
Conduct manual software testing (Positive/Negative, Regression, Smoke, Sanity), defect tracking, and ensure compliance with regulatory guidelines including GAMP5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Contribute to IT compliance activities involving change control, deviation management, CAPA, and periodic review while leveraging knowledge of SDLC methodologies (Waterfall, Agile, V-model) and CSV tools like Valgenesis.
4-12 years of professional experience in Computer System Validation (CSV), Software Testing, and IT Compliance.
Bachelor of Technology or Bachelor of Engineering degree required; specific field of study not explicitly mentioned.
Experience with regulatory standards such as GAMP5, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Knowledge and practical exposure to SDLC and STLC processes including Waterfall, Agile, and V-model methodologies.
Experienced in authoring and managing end-to-end CSV documentation demonstrating strong expertise in GxP environments and IT compliance.
Skilled in manual testing techniques with demonstrated ability to perform thorough defect tracking and reporting within regulated industries.
Familiar with use of CSV-specific tools (e.g. Valgenesis) and capable of integrating compliance and audit processes within evolving software development lifecycle models.