Job Description:

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 rele

📌 Manager (Indore)
🏢 Rubicon Research
📍 Indore