IPQA

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 500,000 - 1,000,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. is seeking an experienced professional for IPQA activities in Hyderabad. The role involves verifying compliance with SOPs, cleanliness standards, and documenting activities in manufacturing and packaging areas.

Responsibilities include ensuring equipment calibration, maintenance of records, and adherence to quality protocols. The ideal candidate will actively participate in ensuring that processes align with current regulations and quality standards.

Responsibilities

• Verify required SOPs displayed are of current version and entry-exit records are in place.
• Ensure cleanliness of area, personal hygiene and gowning procedure as per SOP.
• Verify environmental conditions, area, equipment and cleanliness records.
• Verify weighing balances placement, calibration and maintenance records.
• Give Line Clearance and ensure sampling activities as per SOP.
• Verify calibration and validation for each equipment/instrument as per schedule.
• Verify working conditions of interlocking system in controlled area.
• Ensure status labels affixed and maintained properly.
• Ensure FIFO and FEFO method for dispensing material.
• Check the functioning of machinery before labelling activities.
• Ensure dispensing is done as per BMR & BPR and records are maintained.
• Verify activities adherence to relevant SOPs and BMR & BPR.
• Review executed BMRs & BPRs and update status board.

Job description

Responsible for IPQA activity in facility including Dispensing, Manufacturing & Packing areas.

Responsibilities

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.