Specialist – CSV, ITRA, Advisory

Overview

Specialist role in PwC's Advisory Internal Audit practice, focused on Computer System Validation (CSV), software testing and IT compliance for clients.

What you'll need

• 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.
• 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: CSV.
• Education: M.Sc/B.Pharm/B.Tech; Bachelor Degree required.

Nice to have

• Preferred exposure to CSV tools such as Valgenesis.
• Preferred skill: LIMS/QMS.

Details

• Location: Bengaluru Millenia.
• Line of Service: Advisory; Specialism: Operations; Management Level: Specialist.
• Visa sponsorship: No. Government clearance required: No.
• Job posting end date: June 19, 2026.