Publié il y a 13 jours
QMS, Investigations & CAPA SME
@ United Pharma
Toronto, Ontario
En bref
United Pharma is hiring a senior contractor SME to assess and remediate its quality management system, conduct and review deviation and OOS investigations, and reduce the CAPA backlog. The work covers QMS process improvement, root-cause and product-impact assessments, CAPA effectiveness checks, SOP revisions, and weekly metrics reporting. The role requires 5+ years of pharmaceutical QMS and investigation experience and hands-on work in electronic QMS tools.
Responsabilités :
- Assess and improve QMS processes including deviations, CAPA and audits
- Perform deviation and OOS reviews and lead root-cause assessments
- Write investigation reports and reduce investigation and CAPA backlogs
- Design and run CAPA effectiveness checks and revise SOPs
Résumé des exigences :
- 5+ years pharmaceutical QMS experience
- 5+ years deviation investigations and root-cause analysis
- Demonstrated CAPA effectiveness check experience
- Experience with TrackWise, Veeva Vault QMS or MasterControl
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
- 2026-11-11
- Mise à jour du dossier source
- 2026-11-11
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 | Bureau |
| Position | Surtout assis |
| 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 | 5 |
Role overview
Senior hands-on SME who assesses and remediates the quality management system, conducts and reviews investigations, and drives CAPA backlog reduction and effectiveness. Combines quality systems, investigation and CAPA expertise in a single profile.
Key responsibilities
- Assess and improve QMS processes: deviations, CAPA, change control, audits, management review
- Perform independent reviews of deviations and OOS; lead scientific root-cause and product-impact assessments
- Write and remediate investigation reports to inspection-ready standard; support disposition decisions (final approval remains with the client)
- Reduce investigation and CAPA backlogs through risk-based segmentation and closure acceleration
- Design and execute CAPA effectiveness checks; assess overdue items and prevent recurrence
- Revise SOPs, forms and templates; deliver role-based training to site owners
- Track throughput, cycle time and first-time quality metrics for weekly reporting
Mandatory requirements
- 5+ years assessing and improving pharmaceutical QMS (deviation, CAPA, audit, management review)
- 5+ years in deviation investigations, root-cause analysis (e.g. 5 Whys, Ishikawa, Kepner-Tregoe) and technical writing
- Demonstrated experience designing and executing CAPA effectiveness checks
- Experience with electronic QMS tools (e.g. TrackWise, Veeva Vault QMS, MasterControl)
Plus the common requirements listed on page 1.
Preferred qualifications
- Laboratory / QC background with OOS and OOT investigation experience
- Experience in backlog-reduction or remediation programs
- Solid oral dosage experience
- Root-cause or human-error reduction certification
Journal
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