Key Responsibilities:-
Lead batch preparation, compounding, solution preparation activities- Manage qualification & validation: mixing vessel qualification, SIP validation, filtration validation- Ensure correctness of batch records, logbooks, and data integrity compliance- Lead troubleshooting for compounding deviations and filtration failures- Coordinate with QA/Engineering/Warehouse for seamless production
Technical / Functional Skills:- Expertise in compounding systems and solution preparation- Strong qualification & validation experience (IQ/OQ/PQ, CIP/SIP validation)- Knowledge of filter validation, hold time validation, and mixing studies- Strong understanding of formulation, stability, and compounding dynamics
Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline
Injectables–Specific Expectations:- Experience leading compounding operations for sterile injectables- Understanding of biologic/peptide solution handling- Ability to manage tech transfer & scale-up activities
Experience: 10–12 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (Mandatory)
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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