- Review of completed Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), validation protocols, reports, and associated documentation to ensure compliance with GMP requirements.
- Issuance, control, and reconciliation of Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and other controlled formats in accordance with document control procedures.
- Review and release of semi-finished products after verification of manufacturing documentation, in-process results, and compliance with established specifications.
- Review of electronic data generated during manufacturing and quality-related activities to ensure data integrity and compliance with applicable regulatory requirements.
- Performance of all In-Process Quality Assurance (IPQA) activities, including line clearance, in-process verification, sampling, documentation review, process monitoring, and GMP compliance during manufacturing and packaging operations.
- Support investigations, change controls, deviations, CAPAs, and other Quality Management System (QMS) activities as applicable.
- Ensure compliance with current Positive Manufacturing Practices (cGMP), applicable SOPs, and regulatory requirements while performing all assigned quality assurance activities.
📌 QMS (Pune)
🏢 Emcure
📍 Pune