Operator Manufacturing Injectables

Job Description

• Responsible to perform and monitoring all the activities related to Aseptic area.
• Responsible to perform the cleaning and sanitization of machines, instruments and equipment’s and area.
• Responsible for line clearance activity before commencing the operations.
• Responsible to operate the machines filling, instruments and equipment’s of area.
• Responsible to fill all the records and logbooks related to aseptic manufacturing, filling, cleaning, DP and temperature monitoring.
• To manage the activities related to aseptic area like line clearances before any production activity, aseptic batch manufacturing activity, Filling activity and sanitization activity as applicable.
• Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area.
• Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area.
• Responsible to follow the preventive maintenance schedule of machines, instruments and equipment’s of area and to perform the preventive maintenance of the equipment.
• To follow the cGMP, Good Document Practice and discipline in the department.
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
• Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue.
• Responsible to attend the training as per schedule and to ensure the training and work as per TNI.
• Oversee machine operations, ensuring the adherence to Standard Operating Procedures (SOPs).
• Ensure product quality and compliance with SOPs, industry regulations, and customer specifications.
• To involved in the qualification (IQ/OQ/PQ) of equipments i.e vessels, Ball mill, Dyno mill, Leak testing machine, DPB, Filling machine dispensing booth.
• Conduct routine cleaning, checks on equipment maintenance and ensure adherence to safety protocols.
• Handle production documentation, including batch records, and ensure accurate recording as per AlCOA +.