Machine Operator- Vial Filling
3 weeks ago
Responsibilities:
- Cleaning & Operation of Vial Filling & Sealing Machine / PFS Filling Machine.
- Sterile area cleaning, equipment cleaning and recording of temperature & relative humidity of area.
- Assist in machine setting, assembling/disassembling, format change over and maintenance of Vial Filling machine and PFS Filling Machine.
- Cleaning, Wrapping and storage of Filling Machine accessories and format change parts.
- Assist in the validation activity as per approved protocol like media fill for filling simulation and validation of new equipment.
- Entry of daily operational details in respective log books.
- Coordination with material preparation area for washing, preparation and sterilization of filling machine accessories and primary/secondary packaging material.
- Coordination with warehouse for receiving, storage and transfer of active Raw material, primary and secondary packaging material, semi-finished and finished goods.
- To ensure GMP compliance as per the applicable National and the International regulatory and guidelines such as schedule M & World Health Organization (WHO).
- To carry out the cleaning and sanitization of facility where applicable.
Qualifications - 10+2 / ITI
Experience - 7-10 Years
Required Skills:
- Proficient in operating Vial Filling & Sealing Machines and PFS Filling Machines. This includes starting, stopping, monitoring, and adjusting machine settings.
- Knowledge and experience in cleaning and sterilizing equipment and the sterile production environment according to GMP standards. This includes familiarity with cleaning agents, sanitization methods, and proper documentation.
- Ability to assist with machine maintenance tasks like assembling/disassembling, format changeovers, and troubleshooting minor issues.
- Thorough knowledge and adherence to Good Manufacturing Practices (GMP), including national (Schedule M) etc
- High level of accuracy and precision in machine operation, cleaning, gowning procedures and documentation to maintain quality and sterility.
- Ability to work in a cleanroom environment, potentially involving standing for long periods and performing repetitive tasks
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