Publié il y a 13 jours
Data Integrity SME
@ United Pharma
Toronto, Ontario
En bref
United Pharma is hiring a contract Data Integrity SME to design and run audit-trail reviews, assess equipment and computerized systems, and embed sustainable data integrity controls on the manufacturing floor and in the laboratory. The role requires five or more years of GMP data integrity work and hands-on audit-trail review on lab and manufacturing systems.
Responsabilités :
- Design and execute audit-trail review processes for GMP systems
- Assess equipment and applications for data controls
- Remediate critical forms and paper-based records
- Run retrospective data reviews where required
- Set up and coach a DI champions network
Résumé des exigences :
- 5+ years in data integrity assessments in GMP environments
- Hands-on audit-trail review on lab and manufacturing systems
- Working knowledge of 21 CFR Part 11 and EU Annex 11
- Knowledge of ALCOA+ and MHRA/PIC/S/FDA DI guidance
Outils et compétences
Source et dates
Type de source non vérifié · apify-linkedin
- Date publiée par l’employeur
- 2026-10-28
- Première détection par notre source
- 2026-11-10
- Mise à jour du dossier source
- 2026-11-10
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Senior |
| Domaine | Assurance qualité |
| Expérience | 5 an(s) et plus |
| Milieu de travail | Laboratoire |
| Position | Assis et debout |
| Exigences physiques | physique faible · ordinateur élevé |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
United Pharma
| Champ | Valeur |
|---|---|
| Offres sur Jobsy | 1 |
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
Journal
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