Job Description

To ensure shopfloor compliance as per the GMP norms and ensure on time delivery of the products.

Position / Job Title - Assistant Manager/ Manger IPQA

Department - Quality Assurance: In-Process Quality Assurance

Reporting To - Sr. Manager, In-Process Quality Assurance

Location - Pithampur

Years of Experience - 10-15 Years

Dosage Form - Solid Oral

Job Responsibilities / Deliverables -

Prepare and manage IPQA shift rosters to ensure adequate coverage across all manufacturing and packing areas. Allocate qualified personnel based on activity criticality, workload, and skill matrix. Ensure no gaps during critical operations and maintain backup planning.

Ensure IPQA presence during dispensing, granulation, compression, coating, and packing activities to maintain real-time compliance and control.

Ensure proper line clearance before starting any activity. Verify equipment cleanliness, status labeling, and removal of previous product/material.

Perform and monitor in-process checks such as weight variation, hardness, thickness, disintegration, and coating parameters as per BMR/BPR and SOP requirements.

Conduct real-time and final review of batch documents to ensure completeness, accuracy, and compliance with US FDA expectations.

Initiate and review deviations, out-of-specification (OOS), and out-of-trend (OOT) events. Drive root cause analysis and ensure effective CAPA implementation.

Ensure all manufacturing and packing operations strictly follow SOPs, BMR, and GMP guidelines. Identify and correct non-compliance in real time

Reconciliation of batch at various stages of manufacturing and packing of the batch.

Transactions in software such as SAP, DMS, QMS, e-Logs and other applicable software.

Review of Audit trails/ events and Alarms.

To perform swab/ rinse sampling of manufacturing and packing equipment and submit samples to QC for testing.

Monitoring of reject handling on shopfloor.

Tracking of in-process samples and ensuring timely release of areas for manufacturing and packing.

Identification of opportunity of process and practice improvement on shop floor.

Ensure all time compliance at manufacturing, packing and warehouse shop floor.

Immediate reporting of observed non-compliance to IPQA In charge/ QA Head.

Qualifications & Pre-Requisites

B. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma.

Must have knowledge of working on the shop floor as an in-process quality assurance.

Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA

Exposure to specific dosage forms like OSD.

Effective communication, Team coordination and work in collaboration within compliance

Additional Notes

Role is expected to work in all shifts and all days of the week.

Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.

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