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
- Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported.
- Responsible to perform Stability data trending for investigations and for Annual Stability Summary Review packages for the APQRs to ensure compliance with established timelines and Good Manufacturing Practices.
- Provide required stability data to customers for their product compliance files.
Job Responsibilities
- Prepare Stability Summary Reports within compliance time frame.
- To ensure summary reports are correct and complete as per Apotex procedures.
- Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
- Review Stability data from third party affiliates for compliance.
- Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
- Perform shelf life extensions or reductions for product as required and as per approved procedures.
- Perform trend analysis as requested by the customers and as per approved procedures.
- Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
- Interpret statistical analysis from NWA software.
- Provide Annual Stability Review
📌 Lead Executive (Mumbai)
🏢 Apotex
📍 Mumbai