Computer System Validation Specialist (CSV)
- Location
- Guildford, England, United Kingdom
data integrity. Essential Functions Own and maintain the site Computerised Systems Validation (CSV) Master Plan. Manage the full validation lifecycle of GxP systems (URS, risk assessment, IQ/OQ/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 to ensure compliance with Annex 11 and data integrity requirements. EudraLex Volume 4 Good Manufacturing Practice (GMP) guidelines, laid down ...