|QAP (Quality Assurance Person) Manager Medical Marijuana Licensing, Regulatory, Quality, start-up, and consultation|
Division/Department: Quality Assurance
Industries: Pharmaceutical, Food, NHP
We have several clients looking for QAP (Quality Assurance Persons) for their licensed cannabis production sites for medical marijuana purposes. Ideal qualifications include someone with experience in a highly regulated manufacturing environment such as food & beverage, pharmaceutical, natural health products, or other consumer goods adhering to regulatory bodies such as CFIA, Health Canada, FDA, NCR etc.
This person should have experience in leading 3rd party and internal audits, recall programs, releasing products, writing and reviewing SOP’s, GMP’s, Sanitation programs and general QA / QC experience in a high volume manufacturing facility.
The QAP is accountable for the development, implementation and ongoing monitoring of the quality assurance and control systems in strict compliance with the Access to Cannabis for Medical Purposes Regulations (ACMPR). The QAP is responsible for representing the company’s QA/QC Department in all reports in relations to Health Canada.
- Oversees both quality control (QC) and quality assurance (QA) as per Division 1, Subdivision D and compliance with Health Canada’s QA guidelines pertaining to business, production, facility, security, storage, packaging, labeling and Good Production Practices for the ACMPR program
- Establishing and enforcing GAP, GMP, HACCP and Quality Assurance standards, providing technical and regulatory services in growing inputs, packaging and production of medical marijuana
- Supports continuous quality improvement of medical marijuana through reinforcement of product quality and food safety programs, sanitization program and oversight of security system
- Ability to review regulations, documents and reports pertaining to the ACMPR, Non-confirming Reports (NCR), Corrective Action Reports (CAR), Food and Drugs Act (FDA), Controlled drugs and Substances Act (CDSA) and Pest Control Products Act (PCPA)
- Ability to develop, update and maintain Standard Operating Procedures (SOP) and Quality Manuals
- Oversee critical/technical review of documents, test results, procedures and production equipment, including equipment qualification and validation
- Review certificates of analysis and results of laboratory tests for compliance to specification
- Ensure compliance with regulations through auditing and quality systems
- Investigate product non-conformances; conduct material reviews for complaints, and document findings and responses. Manage product holds, reprocessing actions, and final disposition processes for noncompliant resources
- Manage procedures and processes pertaining to incidents, complaints, deviations and recall
- Manage audit and information requests from Health Canada pertaining to Quality Assurance and Quality Control
- Other responsibilities as assigned
- BS in a technical discipline (Food, Chemical or Biological Sciences preferred)
- 4 to 5 years of experience as a Quality Assurance Manager in a GAP, GMP and HACCP regulated environment, with proficiency quality assurance systems, documentation, testing methods
- Proficient in English (proficient or functional in French is considered an asset)
- Proficient understanding of plant products and related test methodology
- Strong and current knowledge of Division 1, Subdivision 4 guidelines, Good Agricultural Practice, Good Manufacturing Practice, HACCP, Food Safety, regulatory and environmental guidelines
- General understanding of other Operational functional areas
- Experience establishing and maintaining version-controlled standards, policies, procedures and work flows
- Chemistry and Plant Biology knowledge is an asset
- The ACMPR requires candidates to undergo security/background checks, and the individual must be approved by Health Canada as suitable for the QAP role.
Job Type: Full-time