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

Machine Operator/Packing - Manufacturing

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