A leading pharmaceutical company in Solan is seeking a Machine Operator for vial filling and sealing. You will ensure compliance with GMP standards, operate and maintain machines, and assist in cleaning and sanitization of the facility. Ideal candidates should have a 10+2/ITI education and 7-10 years of relevant experience in a similar environment.
Responsibilities
Operate vial filling & sealing machines safely and efficiently.
Ensure compliance with GMP regulations and standards.
Perform cleaning and sanitization of equipment and area.
Assist in the maintenance and troubleshooting of machines.
Sterile area cleaning, equipment cleaning and recording of temperature & relative humidity of area.
Assist in machine setting, assembling/disassembling, format changeover and maintenance of vial filling machine and PFS filling machine.
Cleaning, wrapping and storage of filling machine accessories and format change parts.
Assist in validation activity as per approved protocol such as 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 applicable national and international regulatory guidelines such as Schedule M & WHO.
To carry out 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, including 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.