Assistant Manager

Department Details Role Summary 1 Follow cGMP in production department and online documentation 2 Follow entry exit procedure as per SOP 3 Monitoring and recording of area temperature and differential pressure in the records 4 Monitoring and recording of UV lamp hours in the garment cubicles LAF readings in the records 5 Follow Aseptic practices and Behaviours in Aseptic Area 6 Performing filtration of the formulated solutions for filling 7 Carryout integrity testing of Capsule Filter as per SOP 8 Performing Vial Cartridge filling machine assembly and aseptic connection as per SOP 9 Performing changeover of machine parts with respect to batches 10 Loading Unloading of vials in from lyophilizer 11 Unloading of sterilized articles from the autoclave as per SOP 12 To participate in Aseptic Process Simulation or Media Fill Study Gowning re-qualification as per the schedule plan 13 To provide Personnel monitoring samples Finger DAB Gowns to microbiologist after activity as per SOP 14 To execute Development batches in co-ordination with R D 15 Handling of troubleshooting of the Vial Cartridge filling sealing machine during operations 16 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 17 Monitoring Performing Fogging cleaning of Aseptic Area sealing sterile corridor area 18 Updating of the status board 19 Online updating of BMR Records Checklists Logbook as applicable 20 All documentations to be carried out as per Good Documentation Practices SOP 21 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 22 To report incidents accidents or any deviations immediately to the supervisors 23 To participate in annual cGMP Module SOP BMR Protocol Other Trainings as applicable and keep online updating of the training record 24 3 Performing sealing of liquid filled and lyophilized vials as per SOP 25 To shift the product batch to appropriate cold room for storage 26 Online entry regarding gas purging for filling machine 27 Sending sealed containers to packing area 28 Performing filled volume checks for filled vials cartridges as per SOP BMR 29 Carryout non-viable particle count as per schedule frequency mentioned in SOP 30 Operation calibration of Weighing balance as per SOP Key Responsibilities 1 Follow cGMP in production department and online documentation 2 Follow entry exit procedure as per SOP 3 Monitoring and recording of area temperature and differential pressure in the records 4 Monitoring and recording of UV lamp hours in the garment cubicles LAF readings in the records 5 Follow Aseptic practices and Behaviours in Aseptic Area 6 Performing filtration of the formulated solutions for filling 7 Carryout integrity testing of Capsule Filter as per SOP 8 Performing Vial Cartridge filling machine assembly and aseptic connection as per SOP 9 Performing changeover of machine parts with respect to batches 10 Loading Unloading of vials in from lyophilizer 11 Unloading of sterilized articles from the autoclave as per SOP 12 To participate in Aseptic Process Simulation or Media Fill Study Gowning re-qualification as per the schedule plan 13 To provide Personnel monitoring samples Finger DAB Gowns to microbiologist after activity as per SOP 14 To execute Development batches in co-ordination with R D 15 Handling of troubleshooting of the Vial Cartridge filling sealing machine during operations 16 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 17 Monitoring Performing Fogging cleaning of Aseptic Area sealing sterile corridor area 18 Updating of the status board 19 Online updating of BMR Records Checklists Logbook as applicable 20 All documentations to be carried out as per Good Documentation Practices SOP 21 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 22 To report incidents accidents or any deviations immediately to the supervisors 23 To participate in annual cGMP Module SOP BMR Protocol Other Trainings as applicable and keep online updating of the training record 24 3 Performing sealing of liquid filled and lyophilized vials as per SOP 25 To shift the product batch to appropriate cold room for storage 26 Online entry regarding gas purging for filling machine 27 Sending sealed containers to packing area 28 Performing filled volume checks for filled vials cartridges as per SOP BMR 29 Carryout non-viable particle count as per schedule frequency mentioned in SOP 30 Operation calibration of Weighing balance as per SOP Educational Qualifications Required Education Qualification Msc Required Experience 6 - 10 years