Computerized System Validation (CSV)

Skills:

csv, documentation, Audit review, 21 cfr part 11, gxp compliance, validate system,

We Are Hiring - CSV Engineers (2 Positions)

Role: Computer System Validation (CSV) Engineer

Location: Dabhasa, Gujarat

Experience: 2-4 Years

Open Positions: 2

Key Responsibilities

• Perform monthly audit trail review activities for GxP systems
• Ensure compliance with 21 CFR Part 11, GxP, and Data Integrity guidelines
• Execute CSV lifecycle activities (IQ, OQ, PQ, URS, FS, DS, RTM)
• Review and maintain audit trails, system logs, and user access controls
• Prepare, review, and update validation and compliance documentation
• Support internal and external audits and ensure audit readiness
• Coordinate with QA, IT, and cross-functional teams
• Handle incident, deviation, and change control documentation

• Preparation and review of:
• Validation protocols & reports (IQ/OQ/PQ)
• SOPs, Work Instructions, and policies
• Risk Assessment documents
• Traceability Matrix (RTM)
• Audit Trail Review reports
• Ensure all documents comply with regulatory standards and company procedures
• Maintain proper documentation version control and archival

• Strong knowledge of CSV, GxP, and Data Integrity
• Experience in audit trail review activities
• Hands-on experience with regulated systems (LIMS, QMS, ERP, etc.)
• Good understanding of documentation practices
• Strong communication and coordination skills