Manager - External Quality
On-site · Mumbai, Maharashtra, India or Maharashtra, India
Job Summary
The Manager, External Quality oversees quality activities for Apotex third-party finished product suppliers, ensuring regulatory and cGMP compliance. Responsibilities include liaison with internal/external quality functions, acting as primary contact with third-party organizations, participating in cross-functional product introductions, transitioning R&D to Commercial Quality for co-development/in-licensed activities, developing quality agreements, reviewing third-party validation and change controls, managing investigations into quality incidents and deviations, ensuring CAPA effectiveness, reviewing Annual Product Reviews, and facilitating external audits. Requires strong QA/QC/ manufacturing experience, ability to manage multiple projects, and excellent relationship and communication skills.
Required Qualifications
- Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science
- Excellent understanding of Canadian and US Good Manufacturing Practices
- Experience: Minimum 10 years in pharmaceutical industry with QA/QC/Mfg
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