Description
Description:This role is responsible for performing a variety of tasks related to the processing and assembly of ingredients and pharmaceutical products within a regulated sterile manufacturing environment, with a specific focus on injectable dosage form production. The position operates manufacturing equipment used in the production of injectable pharmaceutical products including filling machines, autoclaves, and filtration apparatus. It handles raw materials and intermediate or finished sterile products in accordance with established aseptic procedures and quality standards. The role supports the preparation and processing of injectable formulations including solutions, suspensions, and emulsions to meet product specifications. It performs general maintenance as required on manufacturing equipment to ensure operational continuity in a sterile workplace. Standard operating procedures are executed to meet current Good Manufacturing Practices and all associated documentation requirements are maintained accurately.
The position ensures full compliance with regulatory requirements including FDA and EMA guidelines applicable to sterile pharmaceutical manufacturing. It actively participates in program or functional team projects aimed at developing process improvement methods and solutions to enhance quality, cost efficiency, and scheduling outcomes.
Essential Functions:
- Operate manufacturing equipment for injectable pharmaceutical production including filling machines, autoclaves, and filtration apparatus in compliance with established SOPs
- Handle raw materials and intermediate sterile pharmaceutical products with accuracy and strict adherence to aseptic technique and safety protocols
- Support preparation and processing of injectable formulations including solutions, suspensions, and emulsions to meet product specifications
- Perform general maintenance on manufacturing equipment as required to ensure operational readiness in a sterile environment
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