Data Integrity SME

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