Job Summary:
The QA position requires excellent time management skills and a proven track record of setting and meeting ambitious goals in the production facility. The QA and Regulatory advisor position will use his/her knowledge and in consulting with others to make necessary changes and recommendations for changes to optimize production or to correct production conditions.
Responsibility and Duties/Tasks:
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Act as liaison between our company and Health Canada, responsible for managing our license applications and amendments.
- In charge of developing and maintaining excellent relations with Health Canada and other regulatory agencies, including timely and professional communications
- Taking the lead in establishing and enforcing GPP, GAP, GMP, and quality assurance standards, and building an efficient and effective Quality Management System.
- Ensure compliance with cannabis laws and regulations pertaining to business, production, facility, security, storage, packaging, labeling, import/export, and distribution.
- Manage all key product quality events/issues, such as regular and random product testing coordination, complaint handling, recall coordination, investigations on deviations/failures, and implementing corrective and preventive actions (CAPA), to close out quality and security gaps across all production sites.
- Work closely with all production sites to ensure that product manufacturing data, notices, and patient management data generated for regulatory submissions comply with relevant regulations and policies.
- Set performance expectations and team goals, execute internal quality audits and performance elevations of QA team members and report regularly to the Executive Management team.
- Propose QA personnel hiring, training, relocation, and promotion plans to higher management, to proactively ensure QA team meeting or exceeding quality and safety targets.
- Other duties as assigned.
Preferred Qualifications:
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Experience working with regulations and compliance such as Health Canada, ISO, GMP.
- Preferably strong knowledge of GMP, Health Canada regulations and Cannabis Act requirements.
- Auditing experience is desirable.
- Experience in Quality Assurance, Quality Control, Document Management, Regulations or Quality Administration in Pharmaceuticals, Research and Development, Medical Laboratory Sciences, Manufacturing etc. is an asset.
- Knowledge working with various ERP systems, such as AmpleOrganic, SharePoint, and Hubspot CRM is an asset.
- Certified Quality Auditor in good standing is considered an asset.
- Certification in LEAN, Six Sigma, Continuous Improvement considered an asset.
- Previous experience developing and implementing training material and/or training programs for auditing considered an asset.
Other Requirements:
- Quality Assurance: 3 years (Required)
Job Type: Full-time
Please send your application to HR@BBTINC.CA with your resume included. We thank everyone for your interest. However, only selected candidates will be contacted.
Position closed.