“The AGM – Quality Assurance is responsible for leading and ensuring compliance of all quality systems in API manufacturing, including documentation control, change management, validation, vendor qualification, batch release, regulatory coordination, deviation/CAPA management, and overall adherence to cGMP and customer requirements.”
Key Responsibilities:
1. Quality Systems & Documentation
2. Change Control Management
3. Vendor & Contract Management
4. Validation & Qualification
5. Batch Release & Compliance
6 Deviation, CAPA & Investigation
7. Technology Transfer
8. Customer & Regulatory Interfac
9. Product Quality & Complaints Handling
10.Quality Monitoring & Governance
Key Skills & Competencies
Education:
Qualification: M.Sc. Chemistry
Experience:
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
