Responsible for executing aseptic filling operations in injectable manufacturing, ensuring compliance with cGMP, aseptic practices, SOPs and regulatory requirements while maintaining product quality and sterility assurance.
Key Responsibilities
1. Perform aseptic filling operations for injectable products in vial filling lines.
2. Operate and monitor automatic and semi-automatic vial filling and sealing machines.
3. Handle aseptic filling activities in Grade A/B cleanroom environments.
4. Perform line clearance, equipment setup, changeover and batch initiation activities.
5. Monitor filling parameters such as fill volume, filling speed, stopper placement and sealing quality.
6. Perform aseptic interventions and routine in-process checks during filling operations.
7. Ensure compliance with environmental monitoring and personnel monitoring requirements.
8. Handle sterilized components such as vials, rubber stoppers and aluminum seals.
9. Execute batch manufacturing record (BMR) documentation and maintain online production records.
10. Coordinate with IPQA, Engineering and Microbiology departments during manufacturing activities.
11.
Participate in media fill simulations, aseptic process validation and qualification activities.
12. Ensure adherence to gowning procedures, aseptic behavior and contamination control practices.
13. Report deviations, breakdowns and abnormal observations to the reporting supervisor.
14. Follow safety procedures and maintain 5S in the manufacturing area.
Technical Skills Required
- Aseptic Vial Filling Operations
- Injectable Formulation Manufacturing
- Automatic Vial Filling & Sealing Machines
- Grade A/B Cleanroom Operations
- Aseptic Techniques and Interventions
- Media Fill Operations
- cGMP & GDP Documentation
- Line Clearance and Changeover
- Environmental Monitoring Awareness
- BMR and SOP Compliance
Preferred Experience
- 46 years of experience in sterile injectable pharmaceutical manufacturing.
- Hands-on experience in aseptic vial filling operations.
- Experience in formulation and filling of liquid or lyophilized injectable products.
- Knowledge of sterile manufacturing practices and contamination control.