Machine Operator

Role Overview: You will be responsible for operating the ampoule filling and capping machine at Dholka premises. Your duties will include maintaining knowledge of operating and maintaining the ampoule filling machine, performing aseptic and processing area entry and exit procedures with proper gowning, and working in the aseptic and processing areas. Additionally, you will be involved in the repair and maintenance of all machines in the parenteral manufacturing area. Key Responsibilities: - Check and ensure that the differential pressure and temperature of the aseptic area and processing area are within limits, and record the readings properly. - Verify that the pressure differentials of all Laminar Air Flow systems are within limits and maintain accurate records. - Monitor in-process parameters such as temperature, relative humidity, pressure differentials, fill volume, and quality of sealing at specified intervals as per the respective MMDI and SOPs. - Maintain proper interpersonal relationships within the section. - Ensure thorough cleaning of the working areas. - Properly label the status of equipment as per SOP guidelines. - Ensure that all required documents comply with cGMP standards. - Report to the Shift In-charge for routine activities and special assignments given by seniors. - Submit reports on performance and progress. - Ensure that calibration certificates of all measuring instruments comply with norms. - Review daily production and discuss any other relevant issues. Qualifications Required: - Knowledge and experience in operating and maintaining ampoule filling machines. - Familiarity with aseptic and processing area procedures. - Ability to perform routine checks on equipment and record data accurately. - Strong attention to detail and adherence to SOPs. - Good interpersonal and communication skills. - Understanding of cGMP standards and documentation requirements.,