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A leading company in the cannabis industry is seeking a Quality Assurance Manager to handle QA and Regulatory Officer responsibilities. This hybrid role involves approving methods and procedures, maintaining quality standards, and ensuring compliance with Health Canada's regulations. Qualified candidates should possess a scientific background and strong critical thinking and communication skills.
Our client is a geographically diversified cannabis group that operates within Health Canada’s Access to Cannabis for Medical Purposes Regulations and distributes globally. They aspire to set best practices by building industry leading companies that transform the perception of cannabis and responsibly elevate the consumer experience. They are comprised of passionate, daring people, driven by quality and integrity who are looking to fill a hybrid Quality Assurance (QA) and Regulatory Officer (RO) role. This person is responsible for both QA and RO responsibilities.
The responsibilities of the QA include approving methods and procedures related to production, packaging, labeling and storage of cannabis prior to their implementation.
The QA is also responsible for releasing and approving each batch of cannabis prior to its sale to clients, this includes keeping complete and auditable batch records. The QA must also initiate recalls, investigate complaints related to quality, investigate quality issues in the facility, perform audits (internal and external) and help train employees.
The responsibilities of the Regulatory Officer (RO) include understanding and helping to implement the regulations (Access to Cannabis for Medical Purpose Regulations), working to write Standard Operating Procedures, responding to communications from the Police, College of Physicians and other requests for information, completing monthly, quarterly and yearly inventory reports in collaboration, participating in Health Canada (HC) audits, drafting permits, section notices and security clearance documents for HC, understanding and monitoring the security systems and working closely with the company CEO, SPIC, and RPIC on all regulatory matters.
DUTIES:
Approve all SOPs prior to their implementation
Sign off on all operational forms
Keep and maintain an auditable batch record
Prepare and send samples for third party testing
Communicate with the third party lab regarding any questions or concerns
Review third party lab results
Approve and release batches for sale to clients
Keep and maintain retention samples from each batch/lot sold
Initiate recall protocols
Investigate client complaints (when related to the quality of the product).
Initiate Corrective Action and Remediation Protocols (CARPs) when investigating quality issues
Approve the use of products (i.e. pesticides, biologicals, nutrients, soil, growing mediums)
Initiate audit programs (regulatory, internal and third party).
Be part of Health Canada inspections.
Communicate with senior staff (CEO,SPIC, RPIC, ARPIC, Head Grower, Production Manager)
Maintain change control program
Develop and maintain an environmental monitoring program
Document Retention
Understand the ACMPR
Draft notices for: Licence Amendments, Renewals, Change in Personnel, General Affairs and Local Authorities. (Sections 38,39,40 and 41 of the ACMPR)
Know the HC deadlines for the above notices and security clearance documents
Draft single or quarterly requests from the Police and/or College of Physicians
Maintain a record of restricted doctors
Take part in HC audits
Maintain complete records that are auditable
Maintain and understand the Security/Camera Systems and complete Corrective Action and Prevention Reports when necessary.
Help develop SOPs and documents related to regulatory affairs
Communicate with client care to ensure ACMPR compliance and Health Canada regarding inquiries and update
The QA must have the ability to think critically and be able to follow regulations and company policies.
Scientific education is recommended, this individual must also be detailed oriented and able to communicate thoughts and ideas to fellow employees and inspectors.
The RO must have the ability to think critically and be able to follow regulations and company policies. Having a regulatory background in manufacturing would be beneficial, this individual must also be detail oriented, able to communicate thoughts and ideas to fellow employees and inspectors and maintain complete and organized documents.
MUST PROVIDE: