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
- Manage deviations, non-conformances, and OOS/OOT investigations
- Conduct root cause analysis and ensure timely and effective CAPA closure
- Track and monitor CAPA effectiveness
Change Control & Risk Management
- Coordinate and implement change control related to manufacturing processes
- Perform risk assessments and ensure mitigation plans are in place
Shop floor Quality Oversight
- Provide real-time QMS support on the shop floor to ensure adherence to procedures
- Ensure line clearance, process compliance, and in-process quality checks
- Coordinate with production, QA, engineering, and warehouse teams
Training & Compliance Culture
- Conduct GMP and QMS training for manufacturing personnel
- Drive quality awareness and compliance culture within the team
Continuous Improvement
- Identify opportunities for process improvement and efficiency enhancement
- Support initiatives such as Lean, Six Sigma, and operational excellence programs
Qualifications & Experience:
- Diploma/Degree in Pharmaceutical Technology, Science, Engineering, or related field
- 4–7 years of experience in manufacturing/QMS/QA within pharmaceutical industry
- Strong knowledge of GMP, QMS, and regulatory requirements and process (granulation, compression, coating and encapsulation)
- Experience handling audits, documentation systems, deviations, and CAPA
- Familiarity with GMP and NPRA requirements
