ASSISTANT MANAGER

Department Details Role Summary 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. 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. participate in annual cGMP / Module/ SOP/ BMR/ Protocol/ Other Trainings (as applicable) and keep online updating of the training record. 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 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. 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. participate in annual cGMP / Module/ SOP/ BMR/ Protocol/ Other Trainings (as applicable) and keep online updating of the training record. 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