Computer System Validation (CSV) Specialist

Vrinda International; Hyderabad, Bengaluru, Chennai District, Pune District; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Vrinda International is seeking an experienced Computer System Validation (CSV) Specialist in India. The candidate will lead CSV activities in GxP environments, ensuring regulatory compliance and data integrity across multiple systems. Strong documentation and cross‑functional collaboration are essential for success.

The role demands executing validation plans, risk assessments, URS, FS, IQ/OQ/PQ, and audit readiness while coordinating with IT, QA, and vendor teams.

Qualifications

• 8+ years of relevant CSV experience.
• Strong knowledge of GxP, GMP and CSV.
• Experience with validation documentation and lifecycle.
• Understanding of 21 CFR Part 11 and data integrity.
• Strong stakeholder and communication skills.
• Experience in regulated Pharma/Life Sciences environments.

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.

Skills

CSV experience

GxP knowledge

Regulatory compliance

Stakeholder communication

Job description

Computer System Validation (CSV) Specialist

Hyderabad | Bengaluru | Chennai | Pune, India | Posted on 08/31/2026

• Country India

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Job Description

HIRING: Computer System Validation (CSV) Specialist

Experience: 8+ Years

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