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 coordination of the pre-marketed stability program within Global R&D;, and for the preparation and review of stability data evaluation reports (e.g., Executive Stability Report, Statistical Evaluation Report, etc.) for regulatory submissions. In a senior role, works closely with other team members, and is accountable for ensuring that stability programs are compliant with current regulatory requirements.



Acts as an area SME during regulatory inspections, and for TrackWise Change Control, QMS Deviation and CAPA management systems.

Job Responsibilities
- Designs, prepares, and reviews stability protocols for R&D; QA pre-approval.
- Evaluates analytical methods to determine suitable quantities of product for stability studies based on the corresponding testing plan.
- Reviews and evaluates stability data for the ongoing stability studies to ensure that significant trends that warrant attention are evaluated. Notify Manager of any concerning trends detected.
- Prepares, reviews, and publishes Stability Summary Reports, Executive reports, Shelf-life extension reports, Statistical evaluation reports, etc. within compliance time frame.
- Prepares and provides stability summary reports, including trend analysis and product evaluations for internal or external customers.
- Performs review of stability summary data provided by third party affil

📌 Executive - Stability Testing (Bengaluru)
🏢 Apotex
📍 Bengaluru