Data Integrity SME
- Toronto, ON, Canada
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Job details
- Job type
- Contract
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- Posting language
- English
- Posted
Original job description
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
More about this job
Responsibilities
Design and conduct audit-trail reviews, assess GMP equipment and computerized systems, and implement sustainable data integrity controls across manufacturing and laboratory settings. Remediate records, perform retrospective reviews, coach data integrity champions, deliver training, and define monitoring metrics; the role may also support laboratory QA governance and analytical error reduction.
Requirements
Requires at least five years of data integrity assessment and remediation experience in GMP environments, including hands-on audit-trail reviews of laboratory and manufacturing systems. Requires working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, and MHRA, PIC/S, and FDA data integrity guidance.
Skills
- Data Integrity Assessments
- Data Integrity Remediation
- Audit-Trail Reviews
- GMP Systems
- Laboratory Instruments
- Equipment and Application Assessments
- Access Controls
- Timestamp Controls
- Data-Lifecycle Controls
- Controlled Records Management
- Retrospective Data Reviews
- Data Integrity Training
- Data Integrity Monitoring
- Laboratory QA Governance
- Data Review
- Analytical Error Reduction
Visa sponsorship
Not detected in the job text
Categories
- Manufacturing
- Science & Research
- Healthcare
- Data & Analytics
- Technology
Keywords
- Data Integrity
- GMP
- Audit-Trail Review
- Empower
- Chromeleon
- LIMS
- SCADA
- HMI
- 21 CFR Part 11
- EU Annex 11
- ALCOA+
- MHRA Guidance
- PIC/S Guidance
- FDA Guidance
- Access Controls
- Timestamp Controls
- Data Lifecycle
- Controlled Records
- Retrospective Data Review
- Data Integrity Monitoring
- Laboratory QA Governance
- Analytical Error Reduction