Assistant Manager - External Quality

About the role

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. Responsible for executing GMP activities related to the corporate governance of Suppliers to global Apotex Manufacturing Sites.

What you'll do

• Negotiates with external suppliers on the provisions of the customer Quality Agreements
• 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

What you need

• 8–14 yrs of experience
• Microbiology
• GMP
• Biology
• Chemistry
• Communication
• B.Sc