Apotex is a Canadian-based global health company. We improve everyday access to affordable, creative 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
Reporting to the General Manager, QA 3rd Party Ops, India, this role is responsible for supporting the Quality Systems required to ensure that Apotex meets its regulatory and GMP compliance obligations for Apotex Suppliers.
Support Managers with compliance activities for Third Party Organizations and Customer Operations.
Responsible for executing GMP activities related to the corporate governance of Suppliers to global Apotex Manufacturing Sites.
Job Responsibilities
- Negotiates with external suppliers on the provisions of the customer Quality Agreements. Makes decisions in consultation with the Manager, External Quality on the respective quality responsibilities to ensure both parties are compliant to GMP and meet Apotex internal standards.
- Responsible for ensuring that Quality Agreements are in place and current for vendors supplying to multiple Apotex Manufacturing Sites.
- Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements and escalate to management when roadblocks occur.
- Monitor and track status of Quality Agreements.
- Provides support to External Quality Managers, in reviewing GMP Quality Documents that form part of Product Compliance Files.
- Reviews third party manufacturer’s Stability protocols and Summary Reports.
- Reviews and approves third party manufacturer’s Change Controls.
- Provides support to Cus
📌 Assistant Manager (Mumbai)
🏢 Apotex
📍 Mumbai
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