Key Responsibilities:

• Handle QMS activities including deviations, change controls, CAPA, and incidents.
• Prepare, review, and maintain SOPs, specifications, and controlled documents.
• Ensure compliance with GMP, GDP, and data integrity requirements.
• Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
• Participate in risk assessments and quality improvement initiatives.
• Support internal audits and external regulatory inspections (USFDA, WHO, EU GMP).
• Track and close QMS elements within defined timelines.
• Ensure proper documentation and record management as per regulatory guidelines.
• Coordinate with Production, QC, Engineering, and other departments.
• Monitor and implement QMS effectiveness across injectable manufacturing.