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Amneal Pharmaceuticals LLC is seeking a professional to operate and monitor injectable manufacturing equipment within a regulated sterile environment in Ahmedabad, India. The role involves handling raw materials, intermediates and finished products to uphold sterility and product quality.
Responsibilities include compounding, filling, batch record completion, equipment maintenance, and strict adherence to cGMP, FDA and EMA guidelines, with opportunities to contribute to process improvements and
Job Description:
This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical injectable products within a regulated sterile manufacturing environment. The position operates and monitors injectable manufacturing equipment and related apparatus to support parenteral product production objectives. It involves the careful handling of raw materials as well as intermediate and finished injectable pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of injectable manufacturing operations including compounding, filling, and related processes in accordance with established formulations and batch manufacturing records. General maintenance activities on injectable manufacturing equipment and related machinery are performed as required to ensure operational continuity. All activities are executed in strict adherence to Standard Operating Procedures and current Good Manufacturing Practices to meet regulatory requirements. Accurate and timely completion of batch records and manufacturing documentation is maintained as a core accountability. The position participates in process improvement initiatives aimed at enhancing quality, reducing costs, and optimizing production scheduling within the injectable manufacturing function.
Experience: 1 - 3 Years