Job Role: Filling Operator
- To follow safety rules in the premises according to the company norms.
- Monitoring of DP, RH and temperature in aseptic processing area.
- To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP.
- Responsible for operation and cleaning of area equipment present in the filling area like filling machine, Rubber stoppering, sealing machines, Isolators, Pass boxes, Glove cleaning and integrity testers including VHP.
- Responsible to carry out the filling, stoppering, lyophilization and sealing operations as per the SOP and BMR.
- Responsible to perform the in process checks during filling.
- To perform aseptic area cleaning and fogging to coordinating with engineering department as per the schedule.
- Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure.
- Operation and Cleaning of heating cooling skid, CIP & SIP skid.
- Responsible for environmental monitoring of (Viable) aseptic processing area.
- Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities.
- Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to aseptic processing area.
- Responsible for cleaning verification and preparation of filling parts for autoclaving.
- Timely completion of SOPs training and on the job trainings related to aseptic processing area.
- Operation and cleaning of all equipments like CIP / SIP for vessels before starting of the batch process and after completion of the batch process related to filling and filtration.
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance
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