Operations Supervisor

3 days ago

Klang, Selangor, Malaysia Manpower Malaysia Full time

RESPONSIBILITIES:

  • 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 Diploma/Degree in Manufacturing/Engineering or a related field.

  • Minimum 3–5 years of hands-on experience in a production department within a GMP-regulated environment.

SKILLS/ABILITIES:

  • Proficiency in English 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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