Promea Therapeutics
Website:
promea.in
Job details:
Responsible for IPQA activity in facility including Dispensing, Manufacturing & Packing areas.
- To verify the required SOPs displayed are of current version and entry-exit records are in place.
- Responsible for ensuring cleanliness of area, personal hygiene and gowning procedure is followed as per SOP.
- To verify the environmental conditions, area, equipment and other accessories like dispensing tools and scoops are clean and records are maintained.
- To verify weighing balances are properly placed and calibration is done at frequency and records are maintained.
- Responsible for giving Line Clearance.
- Responsible for ensuring sampling activities are carried out as per SOP.
- To verify each equipment / instrument is calibrated and validated as per schedule.
- To verify working conditions of interlocking system of controlled area.
- To ensure status labels are properly affixed and are maintained.
- To ensure FIFO and FEFO method are followed for dispensing of material.
- 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.
- To ensure dispensing is carried out as per BMR & BPR and records are maintained.
- To verify whether the activities are carried out in accordance with relevant SOPs and instructions in BMR & BPR.
- 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.
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