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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.
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 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
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.
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.