QMS, Investigations & CAPA SME

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 strong 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.