Key Responsibilities:-
Execute weighing, dispensing, solution preparation, pH adjustment, mixing, and other compounding activities as per BMR.- Supervise preparation of bulk solution for sterile injectables, including biologics and peptide formulations.- Ensure accurate calculation of quantities, yields, and batch reconciliation.- Perform sterile filtration and ensure filtration steps follow validated parameters.- Operate and monitor mixing vessels, jacketed tanks, sterile filtration systems, transfer pumps, and autoclaves.- Ensure equipment cleaning, sanitization, and setup as per SOPs.- Maintain documentation including BMR, logbooks, equipment usage records, and filtration records.- Follow ALCOA and ALCOA+ principles for data integrity.- Ensure adherence to cGMP, USFDA, EU GMP, and Annex 1 guidelines.- Coordinate with QA, Engineering, and Warehouse for timely production.- Train operators and helpers involved in compounding and filtration.
Technical / Functional Skills:- Understanding of cGMP, USFDA, EU GMP.- Knowledge of ALCOA & ALCOA+ data integrity principles.- Hands-on experience in compounding, sterile filtration, and autoclave operations.- Knowledge of aseptic practices, solution stability, and mixing dynamics.- Familiarity with biologic or peptide solution preparation.
Behavioral Competencies:- Positive attitude and strong willingness to learn.- Ethical conduct and honesty in operations.- People management and coordination skills.- Attention to detail and compliance mindset.- Good communication and teamwork abilities.
Injectables–Specific Expectations:- Experience in injectable compounding is mandatory.- Exposure to biologic or peptide product preparation preferred.- Knowledge of sterilization principles, filter integrity checks, and aseptic solution transfers
Experience: 2–3 Years
Qualification: B.Pharm / M.Pharm
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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