Biocon Biologics Ltd
Designation : Executive
Function : Production
Functional Area : Aseptic Manufacturing
Job Role Summary : Aseptic Manufacturing, Filling, Sealing Operations
Job Profile :
- Performing filtration of the formulated solutions for filling.
- Performing sealing of liquid filled and lyophilized vials as per SOP.
- Loading/Unloading of vials in & from lyophilizer.
- Unloading of sterilized articles from the autoclave as per SOP.
- Performing Vial/Cartridge filling machine assembly and aseptic connection as per SOP.
- Performing changeover of machine parts with respect to batches.
- Performing filled volume checks for filled vials/cartridges as per SOP/BMR.
- Carryout non-viable particle count as per schedule/frequency mentioned in SOP.
- Operation/ calibration of Weighing balance as per SOP.
- Handling of troubleshooting of the Vial/Cartridge filling/sealing machine during operations.
- Cleaning and operation of Vial/Cartridge filling machine/ sealing machine/lyophilizer/Mobile LAF/ LAF/ Pass box/ Garment Cubicle/SS articles and other associated equipment/instruments in the filling/filtration area as per SOP.
- To participate in Aseptic Process Simulation or Media Fill Study/ Gowning re-qualification as per the schedule/plan.
- Monitoring/ Performing Fogging & cleaning of Aseptic Area/sealing & sterile corridor area.
- Carryout integrity testing of Capsule Filter as per SOP.
- Monitoring and recording of area temperature and differential pressure in the records.
- Monitoring and recording of UV lamp hours in the garment cubicles, LAF readings in the records.
- To provide Personnel monitoring samples (Finger DAB/ Gowns) to microbiologist after activity as per SOP.
- To execute Development batches in co-ordination with R&D.
- Online updating of BMR/ Records/ Checklists/ Logbook as applicable.
- To ensure that the Preventative maintenance of equipment and instrument has to be performed as per the schedule in co-ordination with maintenance and instrumentation.
- To report incidents, accidents or any deviations immediately to the supervisors.
- To participate in annual cGMP / Module/ SOP/ BMR/ Protocol/ Other Trainings (as applicable) and keep online updating of the training record.
Job Requirements :
1-4 years of experience in Pharma Production, Aseptic operations
Work / Job Experience : 1-4 Years
Type of Experience : Pharma Production aseptic manufacturing and filling line operations
Academic Qualifications :
B. Pharma
