Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.
Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.
Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
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Coordinate and support daily customer delivery activities in collaboration with the Sales team to ensure timely and accurate deliveries.
Liaise closely with internal departments, including Production, Warehouse, Logistics and Sales, as well as external parties, to coordinate delivery schedules and resolve delivery-related matters.
Plan and coordinate daily delivery routes to optimize delivery efficiency and ensure smooth transportation arrangements.
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Experienced for at least 3 years and with exposure to site related works.
Experienced in Oil and Gas / Petrochemical Plant Turnarond (TA) project is an added advantage, particularly manpower planning, work scope estimation and maintenance activities.
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To design water and wastewater treatment projects and ensuring that they are meeting the budget, schedule and specifications.
To have a good understanding on the project specifications and ensure that the project works are in compliance with the specifications and implemented with good engineering practice.
To generate and submit the required drawings, data sheets and documentation for approval and construction.
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Operate and maintain CNC machines including turning centers, 3-axis, 4-axis, and 5-axis mills; perform setup, calibration, tool changes, and routine preventive maintenance to ensure optimal equipment performance and part quality.
Develop, program, and optimize CNC machining routines using Fanuc, Heidenhain, and/or Mitsubishi controls; write, test, and debug machine programs from engineering drawings, CAD models, and work orders.
Create and optimize NC (Numerical Control) programs using Mastercam or similar CAM software; generate efficient tool paths to maximize productivity and part quality while minimizing cycle times and tool wear.
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