Computer System Validation (CSV) Professional

We are looking for an experienced Computer System Validation (CSV) Professional to support validation and quality activities in a regulated GxP environment.

Key Responsibilities

• Collaborate with business, IT, QA, and other stakeholders to understand validation requirements.
• Plan and execute Computer System Validation (CSV) activities across the system lifecycle.
• Prepare, review, and maintain CSV documentation and validation deliverables.
• Review and approve validation documents in accordance with applicable quality procedures.
• Ensure compliance with GxP requirements and 21 CFR Part 11.
• Support QA activities, including SOP preparation, review, and maintenance.
• Maintain quality records and ensure validation documentation is complete and audit-ready.
• Support audits, inspections, deviations, CAPA, and other quality-related activities as required.
• Ensure validation activities follow established organizational procedures and regulatory expectations.

Required Skills

• Strong experience in Computer System Validation / Computerized System Validation (CSV).
• Good understanding of GxP, GMP, and 21 CFR Part 11.
• Experience with validation lifecycle and CSV documentation.
• Knowledge of Data Integrity and regulated computerized systems.
• Experience working with QA and cross-functional stakeholders.
• Good documentation, communication, and stakeholder-management skills.

Location

Mumbai