Quality Assurance Manager
2 months ago
We are looking for a Quality Assurance Manager for our Contract Logistics division based in Mississauga
- ** Your Role **:The Site Quality Assurance Manager will assume overall responsibility for the ongoing development of the Quality Management System within the Contract Logistics business unit(s). You will manage branch and your department Quality functions employing knowledge on: cGMP's, corporate policies, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the tasks (Distribution and Wholesaling) performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). You will report to the site QA manager. #LI-Onsite
- ** Your Responsibilities**:
- Achieve QA operational goals by overseeing and assigning daily activities, identifying and addressing gaps/problems and providing regular feedback to the Director, QA/RA and stakeholders regarding QMS performance and issues
- Support development of WI's and SOP's using experience of GMP's and industry standards
- Hire, manage and develop all QA Specialists within the site; monitor work quality and productivity and maintenance of site QMS
- Member of the Change Control Review Board
- Manage the non-conformity and planned deviation process and oversee the execution of CAPA commitments
- Participate and support, external audits from existing and potential clients and regulatory bodies
- Perform gap analysis and propose action plans to relevant team members to close gaps with the aim to improve the performance of the Quality Management System
- Additional responsibilities applicable to wholesaling may include overseeing: drug product release and documentation (product sampling, review of CoAs, etc.); assess and disposition returned drug product
If you require an accommodation for the recruitment /interview process (including alternate formats of materials, or accessible meeting rooms or other accommodation), please let us know and we will work with you to meet your needs.
**Your Skills and Experiences**:
- 7+ years industry experience in Quality Assurance/Quality Control/Regulatory Affairs
- 2+ years industry experience in Medical Device/Pharmaceutical distribution
- Proficiency in Quality Management systems and standards (i.e. GMP, ISO 13485, 14001, 90001, and 180001)
- Experience with inventory management systems. SAP knowledge is considered an asset
- Experience with GMP's, GDP's, licensing, Federal and Provincial regulations
- Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, or a related discipline) is required; equivalent industry experience may be considered
- Canadian equivalency required if the degree awarded outside Canada or the US
**Good Reasons to Join **:We offer competitive compensation, a comprehensive benefits package, employee discounts, tuition reimbursement, excellent training programs and a highly dynamic global work environment. Kuehne+Nagel’s general working model is a hybrid model depending on the job location, function, etc. The working schedule specific details will be discussed in your job interview. Kuehne+Nagel reserves the right to change or adjust the working model policy.
- **About Kuehne+Nagel***
With over 80,000 employees at some 1,300 locations in over 100 countries, the Kuehne+Nagel Group is one of the world’s leading logistics companies.
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