Job Purpose
To ensure effective implementation, monitoring, and continuous improvement of Quality Management Systems (QMS) within manufacturing operations, ensuring compliance with GMP, regulatory, and company standards while supporting efficient production processes.
Key Responsibilities
QMS Implementation & Compliance
- Ensure compliance with GMP, ISO standards, and internal quality systems in manufacturing operations
- Implement and maintain QMS procedures, policies, and best practices
- Support regulatory inspections, customer audits, and internal audits
Documentation & Record Management
- Review and control manufacturing documents such as BMR/BPR, SOPs, logbooks, and specifications
- Ensure completeness, accuracy, and compliance of batch documentation
- Maintain proper document control and traceability
Deviation, CAPA & Investigation