Employer Background
Our client is a leading organization in the manufacturing sector, operating within a GMP-regulated environment. The employer is dedicated to maintaining the highest standards of quality, safety, and compliance while driving continuous improvement in production performance.
Job Responsibilities
- Manage GMP production orders, including operating steam sterilization (autoclave) machines for sterile garment processing.
- Supervise subordinates, materials, and accessories allocated for production.
- Coordinate manpower allocation for GMP production lines.
- Prepare, review, and maintain GMP documentation such as batch records and SOPs; oversee deviations, change controls, and other quality-related documents.
- Support regulatory inspections and audits by preparing documentation and addressing inquiries.
- Take immediate corrective action on abnormalities within the GMP production area.
- Participate in risk assessments (e.g., FMEA) and conduct root cause investigations for deviations, nonconformities, or OOS events.
- Implement corrective and preventive actions (CAPAs).
- Participate in equipment qualification and validation (IQ/OQ/PQ).
- Collaborate with cross-functional teams including QA, FM, and Purchasing.
- Ensure production targets are met and drive continuous improvement initiatives such as 5S.
- Liaise with FM Department for maintenance and equipment control.
- Update ITS System for laundry management and compile required reports.
- Manage HR-related matters including operator overtime and annual leave.
- Undertake additional job functions as assigned.
Job Requirements
- Diploma/Degree in Manufacturing, Engineering, or a related field.
- 3–5 years of hands‑on experience in a GMP‑regulated production environment.
- Proficiency in English and Bahasa Malaysia.
- Strong leadership skills with the ability to monitor and lead teams effectively.
- Proficiency in computer applications such as Excel, Microsoft Office, and PowerPoint.
- Ability to multitask, apply critical thinking, and work effectively in controlled environments.
- Knowledge of gowning procedures and cleanroom standards (ISO Class 5–8).
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