Title: QMS, Investigations & CAPA SME

Industry: Pharmaceutical / Life Sciences

Location: Canada

Work Arrangement: On-site, with hybrid flexibility subject to client approval

Experience: 5+ years of relevant pharmaceutical quality experience

Job Summary

We are looking for an experienced QMS, Investigations & CAPA SME to support quality system remediation initiatives within the pharmaceutical and life sciences industry. The ideal candidate will have solid hands-on experience in deviation management, root-cause analysis, OOS investigations, CAPA implementation, and quality system improvement.

Roles and Responsibilities

- Assess and improve pharmaceutical Quality Management System (QMS) processes, including deviations, CAPA, change control, audits, and management review.
- Lead and review deviation investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, and other quality events.
- Perform root-cause analysis using methodologies such as 5 Whys, Fishbone/Ishikawa, and Kepner-Tregoe.
- Prepare, review, and remediate investigation reports to ensure accurate, evidence-based, and inspection-ready documentation.
- Evaluate potential product-quality impacts and provide recommendations to support product disposition decisions.
- Drive the timely closure of investigation and CAPA backlogs through risk-based prioritization and effective action plans.
- Develop, implement, and evaluate CAPA effectiveness checks to verify that corrective actions address root causes and prevent recurrence.
- Identify recurring deviations, overdue CAPAs, and systemic quality issues, and recommend sustainable improvements.
- Review and update SOPs, work instructions, quality forms, and investigation templates to improve compliance and consistency.
- Collaborate with QA, QC laboratory, manufacturing, and other cross-functional teams to resolve quality issues and implement remediation activities.
- Provide training and guidance to site personnel on investigation techniques, root-cause analysis, CAPA management, and documentation practices.
- Support inspection readiness and ensure quality records are maintained in accordance with applicable regulatory requirements.

Preferred Qualifications:

- Minimum 5 years of experience in pharmaceutical QMS assessment and improvement.
- At least 5 years of experience in deviation investigations, root-cause analysis, and technical writing.
- Hands-on experience with electronic QMS platforms such as TrackWise, Veeva Vault QMS, or MasterControl.
- Strong knowledge of pharmaceutical quality processes, investigation standards, and regulatory compliance.
- Excellent analytical, documentation, communication, and stakeholder-management skills.
- QC laboratory experience, particularly with OOS and OOT investigations.
- Experience in pharmaceutical quality remediation and investigation/CAPA backlog reduction.
- Exposure to solid oral dosage manufacturing.

📌 QMS, Investigations & CAPA SME (Ontario)
🏢 ALGOBRAINZ
📍 Ontario