Job Description
& Summary: Seeking a Computer System Validation (CSV), Software Testing and IT Compliance. Requires experience in validation deliverables, manual testing, SDLC/STLC, GxP regulations and compliance processes, with LIMS/QMS as preferred skills. Job Position Title: IN_Senior Associate_CSV_Advisory_Bangalore

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), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory skill sets: CSV Preferred skill sets: LIMS/QMS Years of experience required: 4-8 years Education qualification: B.
Pharm/ M.
Pharm/ Other Post graduation

📌 IN_Senior Associate_CSV_Advisory_Bangalore (Bengaluru)
🏢 PwC India
📍 Bengaluru