GMP Supervisor
2 weeks ago
Process all GMP production orders, including operating steam sterilization (autoclave) machines for sterile garment processing.
Supervise line subordinates, materials, and accessories allocated for production.
Coordinate manpower allocation for GMP production lines.
Create and review GMP documentation, including batch records and SOPs; manage deviations, change controls, and other quality-related documents.
Support regulatory inspections and internal/external audits by preparing documentation, explaining processes, and addressing inspector inquiries.
Take immediate action on any abnormalities within the GMP production area.
Participate in risk assessments like FMEA (Failure Mode and Effects Analysis).
Conduct root cause investigations for deviations, nonconformities, or out-of-specification (OOS) events, and implement corrective and preventive actions (CAPAs).
Participate in equipment qualification and validation (IQ/OQ/PQ).
Coordinate cross-functional teams, including QA, FM, and Purchasing.
Ensure the achievement of production targets and continuous improvement (e.g., 5S) of production performance.
Liaise with the FM Department to control maintenance and equipment related to the production line.
Update the ITS System for laundry management and compile reports as required.
Compile and update HQ operator overtime, annual leave, and other HR-related matters.
Undertake any additional job functions as assigned.
QUALIFICATIONS:
Minimum Degree in Manufacturing/Engineering, biotech, chemistry or a related field.
Minimum Diploma with 3–5 years of hands-on experience in a production department within a GMP-regulated environment.
SKILLS/ABILITIES:
Proficiency in English, Mandarin and Bahasa Malaysia.
Strong leadership skills to monitor and lead a group of employees.
Proficient in computer applications such as Excel, Microsoft Office, and PowerPoint.
Ability to multitask and engage in critical thinking.
Knowledge of working effectively in controlled environments, including gowning procedures (e.g., ISO Class 5–8 cleanrooms).
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