Quality Assurance Manager
Prairie Plant Systems, a leader in plant based technologies, is seeking a self-driven individual to join the Quality team in a full-time permanent position. As the Company continues to grow at an exponential pace, the Quality Assurance Manager directly supervises and leads the Quality Assurance team. This person is responsible for various aspects of regulatory and GMP compliance for manufacturing Finished Product including calibration and records for equipment, tools and facilities.
- 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 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
- BSc. In a natural or applied science (biochemistry, chemistry, microbiology, pharmaceutical)
- 5-7 years’ experience in a drug manufacturing environment involving GMP.
- Experience in process auditing, review and approval of documentation, skills to deal with personnel at all levels from regulatory authority to production staff.
- Knowledge of CDSA. NCR, cGMP Standards and ACMPR are considered assets
- Detail oriented.
- Quality Auditor, Quality Management or similar certification is considered an asset.
This position requires occasional entry into a bio secure work area. When entering this area, this employee is required to shower into the facility. The majority of time this employee would be working in normal office environment conditions.
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.
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