Operator Manufacturing Injectables
Amneal Pharmaceuticals
Date: 3 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
B.Sc./Diploma/I.T.I with minimum 02-08 years of experience.
- 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 equipment's 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 +.
B.Sc./Diploma/I.T.I with minimum 02-08 years of experience.
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