Data Integrity SME
- ON, Canada
- Ontario, Canada, Canada
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Job details
- Job type
- Contract
- Apply by
- Experience
- Experience: 5+ years
- Posting language
- English
- Posted
Original job description
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.
More about this job
Responsibilities
Perform audit-trail reviews and assess GMP systems, laboratory instruments, and manufacturing applications for data integrity controls. Identify and remediate gaps, improve documentation practices, establish monitoring and awareness programs, deliver training, and support inspection readiness and laboratory quality oversight.
Requirements
Requires at least five years of experience conducting data integrity assessments and remediation in GMP-regulated environments, including hands-on audit-trail reviews of laboratory and manufacturing systems. Candidates should know 21 CFR Part 11, EU Annex 11, ALCOA+, relevant regulatory guidance, and CSV/CSA, with strong analytical, documentation, problem-solving, and communication skills.
Skills
- Data Integrity Assessments
- Data Integrity Remediation
- Audit-Trail Reviews
- GMP Compliance
- Laboratory Systems
- Manufacturing Systems
- User Access Controls
- Data Lifecycle Management
- Retrospective Data Reviews
- Good Documentation Practices
- Data Integrity Governance
- Training and Awareness
- Analytical Data Review
- Computerized System Validation
- Computer Software Assurance
- Regulatory Compliance
Visa sponsorship
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Categories
- Healthcare
- Manufacturing
- Science & Research
- Consulting
- Data & Analytics
Keywords
- Data Integrity
- GMP
- Audit-Trail Reviews
- Empower
- Chromeleon
- LIMS
- SCADA
- HMI
- 21 CFR Part 11
- EU Annex 11
- ALCOA+
- MHRA Guidance
- PIC/S Guidance
- FDA Guidance
- Computerized System Validation
- Computer Software Assurance
- Data Lifecycle Management
- User Access Controls
- Good Documentation Practices
- Controlled Forms
- Data Integrity Governance
- Retrospective Data Reviews
- Laboratory Quality Oversight
- Analytical Data Review
- Inspection Readiness
- Pharmaceutical
- Life Sciences