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Quality Assurance Manager
Primary Responsibilities
Communication and planning with inspectors and technical authorities on matters of regulatory compliance and quality issues.
Oversight of regulatory compliance and GMP adherence including: procedure approval, oversight of facility, oversight of documentation, inventory control, oversight and review of in-process controls, and the release of raw materials and finished product.
Self-inspection/audit to regularly appraise the effectiveness of controls and defined protocols related to the Quality Assurance System (QAS).
Verification of appropriate procedure training for all staff on MM project including QA management and GMP training
Non-compliance investigation and Corrective Action review and planning (CAPA)
Review and approval of procedures related to production of controlled substances
Ensuring documentation and records are controlled and retained appropriately
Review of monthly and quarterly reporting (inventory) to ensure that inventory is adequately captured
Qualifications
Bachelor of Science in Natural or Applied Science (Biochemistry, Chemistry, Microbiology, and Pharmaceutical) with a minimum of 5-7 years experience in a drug manufacturing/regulatory involving GMP.
Process Auditing, review, and approval of documentation.
Knowledge of CDSA, NCR, Food and Drug Act, and MMPR are considered assets.
Quality Auditor, Quality Management or similar certification considered an asset.
Salary will be based on skill levels and education. PPS offers a comprehensive benefits package. Incumbents will be required to pass a Government of Canada Security check, a criminal record check, a pre-employment drug test, and must hold Canadian Citizenship or Permanent Residence Status.