About Apotex Inc.
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, cutting-edge 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 completion of the projects.
Compile the APQRs within requir