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Quality Assurance Manager

2 months ago

Old Toronto, Ontario, Canada Transarete Full time
Job Description

Transarete is seeking a highly motivated and experienced Quality Manager to join our team in Toronto, ON. As a Quality Manager, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities:
  • Quality Assurance: Support the Operational Management Team in ensuring timely review, follow-up, closure, and approval of various documents, such as master and executed batch records, operational log books, sterilization and depyrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope.
  • Process Failure Investigations: Investigate process failures, deviations, and batch recommendations, and provide supporting reports.
  • Change Control and CAPA: Coordinate investigations, Change Control Requests (CCR's), and CAPA's, and ensure minimal impact on product release.
  • Audits and Compliance: Perform audits in conjunction with Internal Auditor and Vendor Auditor to ensure compliance with cGMP standards, site, and corporate policies.
  • Performance Monitoring and Feedback: Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
Qualifications:
  • Education: Bachelor's Degree/Undergraduate Degree in engineering or technical discipline. Master's Degree preferred.
  • Experience: Required years of experience in pharma quality activities.
  • Skills: Must be detail-oriented as this position will be responsible for and review batch records. Strong working knowledge of Quality System Regulations. Experience leading CAPA (Corrective and Preventive Action) activities.
What We Offer:
  • Competitive Salary and Benefits: Upon successful completion of probation, you will also be enrolled in our benefit programs, including life insurance, long-term disability, dental, and healthcare.