Machine Operator- Vial Filling

3 weeks ago

India, IN Panacea Biotec Full time

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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