The quality assurance person (QAP) is responsible for the development, implementation and ongoing monitoring of quality control systems in strict accordance with the Access to Cannabis for Medical Purposes Regulation (ACMPR) and the Food and Drug Act (FDA). The QAP is responsible for managing day to day site quality assurance operations.
• Aid in the development and maintenance of quality systems that meet government regulations to ensure a high quality product.
• Responsible for ensuring that all production points follow strict QA procedures as a result of SOPs
• Writing, reviewing and maintaining of Standard Operating Procedures.
• Training staff on Standard Operating Procedures and Good Production Practic
• Establishment and maintenance of record keeping systems and ensuring employee adherence to proper documentation practice
• Overseeing premises, hygiene of personnel, equipment cleanliness and maintenan
• Reviewing method validation and equipment qualification protocols and reports (e.g. water system, HVAC)
• Investigation of deviations and/or out of specification results.
• Ensure Corrective Action and Preventative Action (CAPA) investigations are conducted appropriately.
• Review and approve incoming materials.
• Ensure that all lots are produced, packaged, labeled, stored and tested in accordance with regulatory requirements.
• Review of quality complaints and lead investigations.
• Perform quality assurance audits following GPP requirements and participate in internal audits for other AAA Medic production facilities.
Education and Experience:
• Bachelor of Science Degree (Chemistry, Biology, Life Sciences or Pharmaceutical Sciences); additional Regulatory Affairs and Quality Assurance certificate is an asset.
• 5+ years of experience in a quality position within, pharmaceutical, natural health product and/or the Medical Marihuana industry.
• Experience in quality control operations with a producer regulated by the Food and Drugs Act; agri-food processing, pharmaceutical and / or other industries that are certified HACCP Canada.
• Experience in the development and continuous improvement of a cGMP quality management system is an asset.
• Experience and or knowledge with one or more of the following regulations: Access to Cannabis for Medical Purposes Regulation (ACMPR) and the Food and Drug Act (FDA); Food and Drug Regulations; Controlled Drugs and Substances Act (CDSA); as well as Pest Control Products Act (PCPA) and the Fertilizers Act is an asset.
• Experience in an ISO: 9001, ISO: 13485 or ISO: 17025 environments is an asset.