Key Responsibilities

• Prepare, review, issue, and control Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Maintain documentation related to injectable production activities.
• Ensure all entries are completed accurately and in compliance with cGMP practices.
• Coordinate with Production, QA, QC, and Warehouse departments for documentation requirements.
• Review logbooks, equipment records, and process documents for completeness and accuracy.
• Handle document issuance, retrieval, archival, and reconciliation activities.
• Support internal audits, regulatory inspections, and compliance activities.
• Maintain SOPs, formats, specifications, and production-related controlled documents.
• Ensure timely closure of deviations, change controls, and documentation corrections.
• Assist in preparing daily production reports and MIS data.
• Follow data integrity and documentation practices as per regulatory guidelines.