12 Sep
|
Vrinda International
|
Bengaluru
12 Sep
Vrinda International
Bengaluru
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 solid 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
Robust knowledge of GxP / GMP / CSV
Experience with validation documentation and lifecycle
Understanding of 21 CFR Part 11 & Data Integrity
Robust stakeholder and communication skills
Experience in regulated Pharma/Life Sciences environments
📌 Computer System Validation Csv Specialist Bengaluru
🏢 Vrinda International
📍 Bengaluru