Role overview
Data integrity specialist who designs and runs audit-trail reviews, assesses equipment and computerized systems, and embeds sustainable DI controls on the floor and in the laboratory.
Key responsibilities
- Design and execute audit-trail review processes for GMP systems and laboratory instruments
- Assess equipment and applications for access, timestamp, audit trail and data-lifecycle controls
- Remediate critical forms and paper-based records (controlled issuance, reconciliation)
- Run retrospective data reviews where required
- Set up and coach a DI champions network; deliver DI training
- Define sustainable DI monitoring and metrics
- If extended to WS4: support laboratory QA governance, data review and analytical error reduction
Mandatory requirements
- 5+ years in data integrity assessments and remediation in GMP environments
- Hands-on audit-trail review experience on lab and manufacturing systems (e.g. Empower, Chromeleon, LIMS, SCADA/HMI)
- Working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+ and MHRA/PIC/S/FDA DI guidance
