Sr Computer System Validation

CSV Consultant – Responsibilities & Required Competencies

• Carry out CSV activities for GxP-regulated pharmaceutical systems.
• Perform gap assessments and retrospective validation.
• Develop URS, FRS, risk assessments, RTM, IQ/OQ/PQ, and VSR documentation.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.
• Undertake system impact, risk, and data integrity assessments.
• Validate laboratory and manufacturing systems, including PLC, SCADA, and HMI.
• Review test scripts, execution evidence, and validation deliverables.
• Assist with change control, deviations, CAPA, and compliance remediation.
• Maintain audit readiness and Good Documentation Practices (GDP).

We are looking for an immediate Joiners