Computer System Validation (CSV) Specialist

VRINDA INTERNATIONAL; Tamil Nadu; On-site; INR 1,400,000 - 1,500,000; Full time

Job summary

VRINDA INTERNATIONAL is seeking a seasoned Computer System Validation (CSV) Specialist with hands-on experience in GxP-regulated environments. You will execute CSV activities across the system lifecycle and prepare documentation such as URS, IQ/OQ/PQ, risk assessments, and validation plans.

The role requires 4–8 years of CSV experience, strong regulatory knowledge (FDA and GMP), and effective stakeholder management.

Qualifications

• 4–8 years of relevant CSV experience.
• Strong knowledge of GxP / GMP regulatory compliance.
• Experience with CSV lifecycle and validation documentation.
• Knowledge of risk assessment, change control, deviation & CAPA.

Responsibilities

• Execute and support CSV activities across the system lifecycle.
• Prepare and review validation documentation (URS, Risk Assessment, IQ/OQ/PQ, validation plans and reports).
• Ensure compliance with GxP, FDA and applicable regulatory requirements.
• Support audits, deviations, CAPA and change-control activities.
• Work with cross-functional teams to ensure validated systems remain compliant.
• Maintain validation documentation and traceability.

Skills

CSV experience

GxP compliance

Regulatory compliance

CSV lifecycle

Risk assessment

Change control

Job description

HIRING: Computer System Validation (CSV) Specialist

Locations: Hyderabad | Bengaluru | Chennai | Pune

Shift: 12 PM – 9 PM

Experience: 4–8 Years

CTC: ₹14–15 LPA

Domain: CSV | GPV | GxP

Role Overview

We are looking for an experienced Computer System Validation (CSV) professional with strong exposure to GxP-regulated environments and validation processes. The ideal candidate should have hands‑on experience in CSV activities and a good understanding of regulatory compliance and quality systems.

Key Responsibilities

• Execute and support Computer System Validation (CSV) activities across the system lifecycle.
• Prepare/review validation documentation including URS, Risk Assessment, IQ/OQ/PQ, validation plans and reports.
• Ensure compliance with GxP, FDA and applicable regulatory requirements.
• Support audits, deviations, CAPA and change‑control activities.
• Work with cross‑functional teams to ensure validated systems remain compliant.
• Maintain validation documentation and traceability.

Required Skills

• 4–8 years of relevant CSV experience
• Strong knowledge of GxP / GMP / regulatory compliance
• Experience with CSV lifecycle and validation documentation
• Knowledge of risk assessment, change control, deviation & CAPA
• Good communication and stakeholder‑management skills
• Exposure to GPV / Pharmacovigilance environments is an advantage