Executive - IPQA

About this role

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Skills you'll use

What you'll do

• Responsible for carrying out IPQA activities, including line clearance, in-process quality monitoring, review of batch records (BMR/BFR/BPR), sample collection and control sample management, batch release coordination, and participation in validation studies. The role also includes routine GMP compliance verification across manufacturing and warehouse operations, APQR data compilation and trend analysis, vendor documentation review, document archival, and issuance and control of quality documents such as SOPs, specifications, formats, and batch records to ensure compliance with cGMP and regulatory requirements.
• 1. Perform line clearance for dispensing, manufacturing, filling, and packaging operations prior to batch commencement and product changeover to ensure compliance with cGMP requirements.
• 2. Review and verify Batch Manufacturing Records (BMR), Batch Filling Records (BFR), and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with approved procedures.
• 3. Carry out in-process Quality Assurance (IPQA) activities, including monitoring critical process parameters, in-process checks, shop floor surveillance, and ensuring adherence to approved SOPs and cGMP guidelines.
• 4. Manage control samples by ensuring proper collection, labeling, storage, retrieval, and retention in accordance with established procedures.
• 5. Collect and manage in-process, finished product, stability (where applicable), and customer samples as per approved sampling plans and SOPs.
• 6. Compile Annual Product Quality Review (APQR) data, perform trend analysis, and support the preparation of APQR reports to identify opportunities for continuous improvement.
• 7. Participate in process validation, cleaning validation (where applicable), hold time studies, media fill activities (for sterile facilities), and other qualification and validation programs.
• 8. Coordinate batch release activities by reviewing quality documentation, ensuring closure of deviations (where applicable), and facilitating timely disposition of finished products.
• 9. Conduct routine GMP and GDP compliance inspections across Production, Warehouse, Quality Control, Engineering, and other functional areas, and initiate corrective actions for any non-compliance observed.

About Piramal Pharma

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