Senior Quality Assurance Consultant

2 days ago

Vancouver, British Columbia, Canada Cheme Full time

This is an opportunity to join a thriving process engineering firm serving a wide range of industries from pharmaceutical and biologics to science and technology, nuclear, and food and beverage.

Cheme is a team of dedicated professionals that are passionate about what we do and how we do it. Cheme is a place where you will be challenged, supported, and given the freedom and ownership to thrive. We attract the best because we continually invest in our people through career planning, training and development, and mentorship. At Cheme we know that our business is successful when our clients succeed, and our clients succeed when our people reach their potential.

Job Description:

Senior QA Consultant with specialization in equipment and clean utilities. This role will provide leadership and oversight for deviation investigations, quality review and approvals, and compliance activities throughout the project lifecycle. The consultant will act as a strategic quality partner to the client's QA leadership team.

This role can be supported remotely from Toronto but will be required to travel to the Greater Vancouver Area.

Key Roles and Responsibilities will include:

Deviation & Investigation Oversight

  • Review and approve documents for equipment, clean utilities, and cleanroom systems.
  • Ensure timely, compliant investigations with clear root cause analysis and effective CAPAs.
  • Act as senior QA approver for complex, multi-system investigations.
  • Prepare and present risk assessments and recommendations to stakeholders.

Project Leadership & Support

  • Mentor QA reviewers and assist with workload allocation for high-impact investigations.
  • Collaborate with stakeholders on root causes, CAPAs, and process improvements.

Documentation & Compliance

  • Review and approve CQV protocols, tech transfer documents, and verification reports.
  • Participate in change control and master document updates.
  • Ensure compliance with GMP, ICH, and investigation procedures.

Team & Client Collaboration

  • Serve as liaison between consulting team and client QA leadership.
  • Escalate critical failures to corporate QA.
  • Promote a collaborative, high-performance team environment.

Qualifications

  • Degree in engineering or science (asset, not mandatory).
  • 10+ years QA experience in GMP systems (pharma or food/beverage).
  • Experience in pharma/biotech manufacturing.
  • Ability to review engineering design docs (P&IDs, electrical drawings, specs).
  • Knowledge of cGMP, GDP, and regulatory standards (FDA, Health Canada, EU).
  • Familiarity with ASTM E2500 risk-based validation.
  • Experience with equipment qualification, clean utilities, and deviation investigations.
  • Proficiency in electronic quality systems (e.g., Kneat, TrackWise, SAP, LIMS).

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