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IN_Associate_CSV_ITRA_Advisory_Mumbai

📍 PwC • Shivaji Park, Maharashtra, India • Posted June 10, 2026

Full-time Posted June 10, 2026
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Job Description

Description

& Summary: A Career with in..................

Responsibilities

  • Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
  • Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). 
  • Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. 
  • Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis)
  • Knowledge of GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. 
  • Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. 
  • Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications(URS), Functional Requirement Specifications(FRS), Fun...

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