Qms Executive

Key Responsibilities

• QMS Compliance & Documentation
  
• Prepare, review, and maintain SOPs, Batch Manufacturing Records (BMR), and related production documents.
• Ensure timely closure of deviations, change controls, and CAPAs related to production activities.
• Maintain compliance with global regulatory standards.
• Batch Execution & Monitoring
  
• Monitor batch manufacturing processes to ensure adherence to approved procedures.
• Coordinate with QA for line clearance and in-process checks.
• Deviation & Investigation Handling
  
• Initiate and investigate production-related deviations.
• Prepare investigation reports and implement corrective and preventive actions (CAPA).
• Training & Compliance
  
• Conduct training for production staff on cGMP, SOPs, and QMS requirements.
• Ensure readiness for regulatory audits and inspections.
• Continuous Improvement
  
• Participate in root cause analysis and process improvement initiatives.
• Support implementation of data integrity practices and electronic documentation systems.