About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, cutting-edge medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative 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

Responsible for the following aspects of the Annual Product Review program;
Compile annual product quality reviews (APQRs) per applicable SOPs.
Collect, analyse and summarize product review data correctly and completely in timely manner.
monitoring of execution of APQRs as per due dates
Liaising with Project Leaders at Apotex
Review of summary reports ensuring collected data is accurate and conclusions are appropriate.




Accountable to ensure the compiled annual product reviews and supplementary reports are conducted in a timely manner as per established procedures.
Responsible to escalate any critical issues arising from the Product Review.
Acts as a technical resource and coach for the business units- internal and external stakeholders and affiliates in regard to the Annual Product Review quality system.

Develop and mentor the APQR compilers to meet the compliance levels.
Timely Co-ordinate with team and GBS QMS team for Departmental Assigned Training in SAP My HR.
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 & Specification
Manufacturing / Process Validation, Equipment & Utilities Qualification
Sterility Validation / Qualification (If applicable)
Packaging Compo

📌 Lead Executive (Mumbai)
🏢 Apotex
📍 Mumbai