Computer System Validation (CSV) Specialist

HIRING: Computer System Validation (CSV) Specialist

Locations: Hyderabad | Bengaluru | Chennai | Pune

Experience: 8+ Years

CTC: ₹18–20 LPA

Domain: CSV | GPV | GxP

Role: Computer System Validation (CSV)

Role Overview

We are looking for an experienced Computer System Validation (CSV) professional with strong expertise in GxP-regulated environments and validation processes. The ideal candidate should have hands-on experience managing validation activities and ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Lead and execute CSV/CSA activities across GxP systems.
• Prepare and review validation plans, risk assessments, URS, FS, IQ/OQ/PQ and validation reports.
• Ensure compliance with GxP, GMP, FDA 21 CFR Part 11 and data integrity requirements.
• Support system lifecycle activities, change control, deviations and CAPA.
• Coordinate with IT, QA, business and vendor teams.
• Conduct validation documentation review and ensure audit readiness.
• Support internal and regulatory audits.

Required Skills

8+ years of relevant CSV experience

Strong knowledge of GxP / GMP / CSV

Experience with validation documentation and lifecycle

Understanding of 21 CFR Part 11 & Data Integrity

Strong stakeholder and communication skills

Experience in regulated Pharma/Life Sciences environments