Quality Assurance Associate – Pharmaceuticals – Mississauga

The Quality Assurance Associate will be primarily responsible for preliminary review of documents for product release. Quality responsibilities will also include review of executed batch documents and tracking of testing at Third Party labs and tracking of Stability data.

1. Responsible for the timely co-ordination of finished product testing, review of required quality documentation for release of finished products to market. This involves ensuring that all GMP documentation is correct and compliant.
2. Ensure SOPs for all applicable elements of product importation, distribution, testing, warehousing, and quality assurance are followed and in compliance with current Health Canada’s GMPs and best industry practices.
3. Assist with recall of any defective products and for the execution of the recall as required by Company policy and Health Canada.
4. Responsible for the approval of products intended for destruction.
5. Responsible to do Temperature downloads, and define and execute temperature mapping, when applicable.
6. Coordinate with Warehouse staff for incoming product inspection and label review.
7. Maintain retain sample inventory for active products and submission samples for future products including annual retain sample physical inventory.
8. Communicate in a timely manner finding related to documentation and release issues including but not limited to delays in receiving documentation from Contract Fabricators, deviation investigations etc.
9. Review of executed batch records.
10. Collect and/or review technical records from foreign sites for example, method and process validation protocols and reports
11. Tracking Stability for commercial and submission lots on an ongoing basis and ensure Stability for products to support shelf life is filed.
12. Interface with 3rd party and foreign site organizations on GMP matters to resolve quality matters as required and/or meet Canadian GMP requirements
13. Any other duties as assigned by the Senior Director – Drug Safety, Quality & Compliance.