Title: QUALITY ASSURANCE MANAGER, QAP
Department name: Quality Assurance
Job type: Permanent, Full time
Overall Objective: The Quality Assurance Person’s (QAP) key role is to ensure the integrity of the Licence Holder’s products. The QAP ensures that the manufacturing and sale of products are done according to Health Canada regulations. This function maintains quality compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). The quality function also ensures the timely release of products for sale.
Manage the Quality Control (QC)/Quality Assurance (QA) including but not limited to lot management, stability study review, maintenance of quality agreements, the release of products for sale, product inspection (audits), vendor qualification, pest control management, sanitation program management, training of employees on GPP and preparation & development of SOPs. This role is also responsible for document management, archiving of QA/QC records and responding to any compliance-related issues at the Licence Holder.
- Maintain Licence Holder’s product list.
- Lead Regulatory projects that involve QA oversight including stability changes, updates to labelling etc.
- Assist and coordinate with new launch shipments.
- Manage and evaluate (trending) product complaints, deviations, Corrective Actions and Preventative Actions (CAPAs).
- Development, review, revision and implementation of SOPs as required.
- Annual product reviews and reviews of stability reports for compliance.
- Manage the maintenance of quality agreements with manufacturers, wholesalers and distributors.
- Conduct inspections of Labs or vendors as necessary as per GMP requirements
- Act as primary quality contact person with Third Party Logistics (3PL) and as a qualified person for internal quality compliance matters
- Implement recall procedures if necessary and perform mock recall yearly to ensure recall procedures are adequate.
- Monitor QA aspects of finished product storage and shipping practices for compliance.
- Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
- Timely approval of batches, batch inspection and perform release for sale according to Licence Holder’s SOP.
- Maintaining appropriate documentation (i.e., COAs) and ensure document compliance according to GMPs.
- Managing deviation and CAPA reports.
- Managing returns (RTV).
- Managing on-site retained samples according to GMP.
- Maintaining QC master documents for all registered products.
- Ensure compliance with appropriate SOP’s, policies and guidelines.
- Complete mandatory training in assigned timelines upon hire as well as when new policies, SOPs, and guidelines are issued.
- Participate in personal development and training sessions as required for the position.
- Strive to consistently uphold Licence Holder’s core values.
- Execute other duties as may be required by Executive team members and other members of Licence Holder’s Team.
If interested in this opportunity, please contact email@example.com with the job title in the subject line.