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

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📌 Data Integrity SME (Ontario)
🏢 United Pharma
📍 Ontario