Machine Operator- Vial Filling & Sealing

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

Experience

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