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

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
Solid 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.
Positive documentation, communication, and stakeholder-management skills.

Location

Mumbai

📌 Computer System Validation Csv Professional Mumbai
🏢 Quess IT Staffing (Formerly known as Magna Infotech)
📍 Mumbai