Job Description
We Are Hiring CSV Engineers (2 Positions)
Role: Computer System Validation (CSV) Engineer
Location: Dabhasa, Gujarat
Experience: 24 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)
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- 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
Skills
AuditAudit TrailAudit TrailsAuditsChange ControlExternal AuditsErpQaQmsSopsIf an employer asks you to pay any kind of fee, please notify us immediately. Jobaaj does not charge any fee from the applicants and we do not allow other companies also to do so.
Important dates & deadlines?
Application Deadline
27 Jul 26, 02:12 PM IST
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