Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, creative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
- Compile annual product quality reviews (APQRs) per applicable SOPs.
- Collect, analyse and summarize product review data correctly and completely in timely manner.
Job Responsibilities
- Perform Annual Product Quality Reviews (APQRs) compilation as assigned. This includes the following at minimum, as per SOP:
- Manufacturing Process Overview
- Batches Released / Rejected
- APIs, Excipients
- Changes
- Test Method and Specification
- Manufacturing / Process Validation,
Equipment and Utilities Qualification
- Sterility Validation / Qualification (If applicable)
- Packaging Component Deviations/Changes
- Compendial Review
- Deviations
- Critical In-Process Attributes
- Analytical Test Results
- Recalls and Field Alerts, Returns
- Retention Samples Review
- Technical Agreements (as appropriate)
- Marketing Authorizations Variations and Post Market Commitments (as appropriate)
- Complaints
- Stability
- Conclusion and Product Rating
- Concerns, Recommendations and Issues for Follow-Up
- Perform complete and correct transactions of the data as per SOP / WI’s.
- Summarize and trend analytical data from LIMS or other acceptable systems.
- Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
- Co-ordinate with Project Leader(s) – QA Product Review / Manager for compl