Officer, QMS

Description: 

• Manage, control, and maintain all Quality Assurance (QA) documents, records, and logs in compliance with GMP requirements.
• Ensure timely issuance, retrieval, archival, and destruction of controlled documents according to approved procedures.
• Maintain document revision history and ensure only current, approved versions are available for use.
• Coordinate document review, approval, and distribution processes with QA, Production, QC, and other departments.
• Monitor compliance with document control procedures and support internal audits and regulatory inspections.
• Maintain electronic and physical document management systems, ensuring data integrity and confidentiality.
• Track periodic review schedules for Standard Operating Procedures (SOPs), specifications, forms, and quality manuals.
• Support change control activities by updating and distributing revised documents as per approved changes.
• Prepare document control metrics, reports, and status updates for management review.
• Ensure all documentation practices comply with applicable regulatory guidelines, including GMP, WHO, FDA, MHRA, and company quality standards.

Additional Responsibilities:

• Issue approved Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated controlled documents to Production as per the production plan and document control procedures.
• Verify the completeness, correctness, and revision status of batch records before issuance, maintain issuance logs, and ensure reconciliation and retrieval of executed batch records after batch completion.