📢 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

📄 Documentation Responsibilities:

• 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

💡 Required Skills:

• 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