QMS, Investigations & CAPA 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
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
More about this job
Responsibilities
Assess and improve QMS processes, independently review deviations and OOS cases, lead root-cause and product-impact assessments, and produce inspection-ready investigation reports. Reduce investigation and CAPA backlogs, design effectiveness checks, update procedures and training materials, and report quality performance metrics.
Requirements
Requires at least five years of experience improving pharmaceutical QMS processes and at least five years conducting deviation investigations, root-cause analysis, and technical writing. Candidates must have experience designing and executing CAPA effectiveness checks and using electronic QMS tools; laboratory/QC, OOS/OOT, remediation, solid oral dosage, or root-cause and human-error reduction experience is preferred.
Skills
- Quality Management Systems
- Deviation Investigations
- Root-Cause Analysis
- CAPA Management
- OOS Investigations
- Product-Impact Assessment
- Investigation Report Writing
- CAPA Effectiveness Checks
- Risk-Based Backlog Reduction
- Change Control
- Audit Management
- SOP Revision
- Role-Based Training
- Electronic QMS
- Quality Metrics Reporting
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Manufacturing
- Management & Leadership
- Consulting
Keywords
- Pharmaceutical Quality Management System
- Deviations
- CAPA
- Change Control
- Audits
- Management Review
- OOS
- OOT
- Root-Cause Analysis
- 5 Whys
- Ishikawa
- Kepner-Tregoe
- Product-Impact Assessment
- Investigation Reports
- Risk-Based Segmentation
- CAPA Effectiveness Checks
- SOPs
- Electronic QMS
- TrackWise
- Veeva Vault QMS
- MasterControl
- Laboratory
- Quality Control
- Backlog Remediation
- Solid Oral Dosage
- Human-Error Reduction
- Cycle Time
- First-Time Quality