IPQA - Executive

Promea Therapeutics; Hyderabad; On-site; INR 400,000 - 800,000; Full time

Job summary

Promea Therapeutics is seeking an IPQA professional in Hyderabad responsible for overseeing quality assurance activities in the dispensing, manufacturing, and packing areas. You will ensure compliance with SOPs, maintain cleanliness, and verify environmental conditions.

The role includes providing Line Clearance, verifying equipment calibration, and ensuring documentation in compliance with BMR & BPR. This position offers an opportunity to contribute to crucial quality processes in a dynamic environment.

Responsibilities

• Responsible for IPQA activity in facility including Dispensing, Manufacturing & Packing areas.
• Verify required SOPs are current and entry-exit records are in place.
• Ensure cleanliness of area and compliance with personal hygiene and gowning procedures.
• Verify environmental conditions, equipment cleanliness, and record maintenance.
• Ensure weighing balances are calibrated and records are maintained.
• Provide Line Clearance and ensure sampling activities are per SOP.
• Verify equipment calibration and validation per schedule.
• Check working conditions of interlocking system in controlled area.
• Affix and maintain status labels properly.
• Ensure FIFO and FEFO methods are followed for dispensing.
• Verify machinery functionality before labeling activities.
• Confirm dispensing as per BMR & BPR, with records maintained.
• Ensure activities comply with relevant SOPs and instructions in BMR & BPR.
• Review executed BMRs & BPRs and update the status board.

Job description

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.