promeatherapeutics
Responsible for IPQA activity in facility including Dispensing, Manufacturing & Packing areas. 1. To verify the required SOPs displayed are of current version and entry-exit records are in place. 2. Responsible for ensuring cleanliness of area, personal hygiene and gowning procedure is followed as per SOP. 3. To verify the environmental conditions, area, equipment and other accessories like dispensing tools and scoops are clean and records are maintained. 4. To verify weighing balances are properly placed and calibration is done at frequency and records are maintained. 5. Responsible for giving Line Clearance. 6. Responsible for ensuring sampling activities are carried out as per SOP. 7. To verify each equipment / instrument is calibrated and validated as per schedule. 8. To verify working conditions of interlocking system of controlled area. 9. To ensure status labels are properly affixed and are maintained. 10. To ensure FIFO and FEFO method are followed for dispensing of material. 11. To ensure prior to the labelling activities the machine for pressure leak test, visual inspection booth, flow wrap, flow wrap machine, packing conveyor are functioning properly and are calibrated and validated. 12. To ensure dispensing is carried out as per BMR & BPR and records are maintained. 13. To verify whether the activities are carried out in accordance with relevant SOPs and instructions in BMR & BPR. 14. Ensure that the BMR & BPR is available and completed up to the previous stage and status board updated as per forthcoming batch BMR & BPR and responsible for review of executed BMRs & BPRs.