Computer System Validation Specialist (CSV)
- Location
- Guildford, England, United Kingdom
/PQ, validation reports). Assess and approve system updates, configuration changes, and upgrades in line with change control procedures. Conduct risk-based impact assessments for system changes and new implementations. Perform and document periodic system reviews to ensure ongoing validated state. Identify and close existing CSV gaps … assessment, validation, and lifecycle management. Practical experience validating GxP computerised systems in accordance with EU GMP Annex 11 and GAMP5. Experience conducting system risk assessments, change impact assessments, and periodic reviews. Experience supporting regulatory inspections (e.g., MHRA, FDA) relating to computerised systems and data integrity. Knowledge, Skills ...