Description:
This role is responsible for performing a diverse range of tasks related to the processing and assembly of pharmaceutical ingredients and finished products within a regulated sterile manufacturing environment. The position operates and monitors filling and sealing equipment and related manufacturing apparatus to support parenteral and sterile product production objectives. It involves the careful handling of raw materials as well as intermediate and finished pharmaceutical products to maintain product integrity, sterility, and quality. The role contributes to the execution of filling and sealing operations for injectable and sterile dosage forms in accordance with established formulations and batch manufacturing records. General maintenance activities on filling machines, sealing 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 filling and sealing function.
Essential Functions:
- Operate and monitor filling and sealing equipment and related manufacturing apparatus in accordance with validated procedures and GMP standards.
- Handle raw materials, intermediate products, and finished sterile goods with care to maintain product quality, sterility, and prevent contamination.
- Perform filling and sealing operations for injectable and sterile dosage forms per approved batch manufacturing records.
- Mix and compound ingredients for liquid products, suspensions, and sterile formulations per approved procedures as required.
- Conduct general maintenance on filling machines, sealing equipment, and related apparatus to ensure operational readiness.
- Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.
- Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.
- Participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
Support area cleaning and sanitization activities to maintain a compliant and sterile manufacturing environment.
Additional Responsibilities:
