31 Aug
|
Vrinda International
|
Bengaluru
31 Aug
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 robust 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
Solid stakeholder and communication skills
Experience in regulated Pharma/Life Sciences environments
📌 Computer System Validation Csv Specialist Bengaluru
🏢 Vrinda International
📍 Bengaluru