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 affiliates (e.g., contract laboratories) for completeness and compliance.
- Provides day to day technical support, direction, and guidance to the R&D; Stability team members, including problem solving and troubleshooting of stability program related issues, and suggests remedial and corrective actions, when required. Acts as an area SME on TrackWise - Deviation and CAPA management system.
- Proficient in creating and verifying stability protocols in LIMS, and initiating stability studies.
- Prepares and oversees the execution of the monthly stability pull schedule, and assists with the preparation of different

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