Quality Assurance Specialist
3 weeks ago
We are looking to hire a Quality Assurance Specialist for our Contract Logistics division/office based in Mississauga.
- ** Your Role **:The Quality Assurance Specialist I will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local level within the assigned business unit(s), in accordance to Distribution and/or Wholesaling requirements, as applicable. This role will execute branch Quality functions employing knowledge including but not limited to: cGMP's, corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). The ARPIC will assume full responsibility for all transactions involving precursors. The AQPIC will assume responsibility for all transactions involving controlled and targeted substances.
- ** Your Responsibilities**:
- You will assist the flow of Operations including Inbound, Returns, Destruction, Outbound, Retention etc. where Quality support may be required.
- You will release or quarantine product in accordance to client or Kuehne+Nagel instructions and regulatory requirements.
- You will inspect finished products and oversee the sampling of these products for testing and retention purposes in accordance to client or Kuehne+Nagel requirements.
- You will support product complaint/inquiry requests or investigations in accordance to client or Kuehne+Nagel requirements.
- You will maintain site documentation control and records retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation.
- You will monitor the daily operational transactions of CDS (Controlled Drugs and Substances) /PCR (Precursor Control Regulations) products and fulfil regulatory reporting obligations per OCS (Office of Controlled Substances) regulations.
Other tasks as may be assigned relative to the assigned sites in the Pharma/Healthcare Canadian region.
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**:
- 1+ years industry experience in Medical Device/Pharmaceutical industry in QA. RA experienced may be considered 2+years industry experience in Medical Device/Pharmaceutical distribution.
- Basic knowledge of Quality Management systems and standards (i.e.: GMP, ISO 13485, ISO 9001).
- Experience with GMP's, GDP's, licencing, Federal and Provincial regulations.
- Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, or a related discipline) is required.
- Canadian equivalency required if the degree was 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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