Title:Data Integrity SME
Industry: Pharmaceutical / Life Sciences
Location: Canada
Experience: 5+ years
Job Summary:
We are looking for an experienced Data Integrity Subject Matter Expert (SME) to support data integrity assessments and remediation initiatives within a regulated pharmaceutical environment. The ideal candidate will have hands-on experience with audit-trail reviews, laboratory and manufacturing systems, GMP compliance, and data integrity controls.
Roles and Responsibilities
- Develop and perform audit-trail reviews for GMP systems, laboratory instruments, and manufacturing applications.
- Assess computerized systems and equipment for user access controls, timestamps, audit trails, and data lifecycle management.
- Identify data integrity gaps and implement practical remediation measures in line with regulatory expectations.
- Review and improve paper-based records, controlled forms, issuance processes, and document reconciliation practices.
- Conduct retrospective data reviews and investigate potential data integrity issues where required.
- Establish data integrity monitoring processes, performance metrics, and sustainable control mechanisms.
- Develop and support a Data Integrity Champions network to promote awareness and accountability across site teams.
- Deliver training to QA, QC, laboratory, and manufacturing personnel on data integrity principles and good documentation practices.
- Collaborate with cross-functional teams to strengthen GMP compliance and maintain inspection readiness.
- Where required, support laboratory quality oversight, analytical data review, and initiatives to reduce laboratory errors.
Preferred Qualifications
- Minimum 5 years of experience in data integrity assessments and remediation within GMP-regulated environments.
- Hands-on experience performing audit-trail reviews on laboratory and manufacturing systems such as Empower, Chromeleon, LIMS, SCADA, or HMI.
- Working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and applicable MHRA, PIC/S, and FDA data integrity guidance.
- Strong analytical, documentation, problem-solving, and communication skills.
- Knowledge of Computerized System Validation (CSV) and Computer Software Assurance (CSA).
- Experience establishing data integrity governance programs, monitoring metrics, and site-wide awareness initiatives.
