Posted 17 days ago
QMS, Investigations & CAPA SME
@ United Pharma
Toronto, Ontario
Overview
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.
Responsibilities:
- 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
Requirements summary:
- 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
Tools & skills
Source and dates
Source type not verified · apify-linkedin
- Employer posting date
- 2026-10-28
- First seen by our source
- 2026-11-11
- Source record updated
- 2026-11-11
These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.
Job details
| Seniority | Senior |
| Department | Quality assurance |
| Experience | 5+ years |
| Work setting | Office |
| Position | Mostly sitting |
| Physical demands | physical low · computer high |
Summary and details written by AI from the posting; the employer’s posting is the authority.
United Pharma
| Field | Value |
|---|---|
| Open jobs on 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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