Ch Leong Email & Phone Number

Batu Kawan, Penang

1. Process/product transfer and process validation - lead overall validation activities and coordinate with cross-functional departments to ensure efficient and timely delivery of all validation activities.2. Material/packaging/alternative supplier qualification - lead overall qualification activities for packaging material localization – corrugated cartons, pouches, medical trays, Tyvek lids, labels, thermal transfer ribbons, IFU, tape, etc.3. Review & coordinate supplier process validation activities – medical tray thermoforming process and PVC tubing extrusion process.4. Change management/control – lead overall activities from scoping to implementation for change related to Supplier Change Notification (SCN), assembly process improvement, and cost saving initiatives. Initial release/update component/product drawing, Bill of Material (BOM), manufacturing instructions (MI) via Engineering Change Order (ECO).5. Subject Matter Expert (SME) for process improvement – minimize/prevent workmanship errors by introducing poka-yoke fixtures.6. SME for sterilization palletizing load pattern/configuration.7. Expand product portfolio – local project lead to support Corporate in any task related to product expansion & product registration in various countries. Cost sheets and Oracle item setup local lead.8. Calibration/Preventive Maintenance/Equipment Change Control - develop & maintain local procedures for calibration, equipment preventive maintenance & equipment change control.9. Internal quality auditor of the company.10. NCE/CAPA handler – Investigate root cause, perform impact analysis and perform correction on the non-conformities.11. SME for external audits – responsible to answer audit questions on process validation, packaging/material localizations, calibration, preventive maintenance, change control, NCEs, and CAPAs.12. Coach & Mentor – coaching & mentoring peers for process validation, packaging/material localization & change control.

Penang, Malaysia

Penang, Malaysia

- Conduct engineering studies/protocols/reports for process improvement, increase productivity, quality, reduce scrap rate, and cost saving projects.- Conduct process capability studies to revise existing process parameters and establish new process parameters for process/equipment.- Perform Statistical Analysis in validation engineering, material science, packaging engineering, and automation & controls engineering.- Establish process improvement activities; LEAN SIGMA, SPC & OEE in production.- Solving production and technical related problems by conducting investigation or evaluation to detect the root causes of problems, with reference to CAPA.- Manage capacity expansion projects.- Lead process validation activities for new machine buy off, machine transfer from different facilities, and machine relocation within same facility.- Support software validation activities for machine vision system.- Support process validation activities for new facility utilities – compressed air system, vacuum system, air conditional system, exhaust system, electrical system, deionized water system and process cooling water system.- Manage data collection and perform statistical analysis for process validation activities.- Maintain the state of validated process/process equipment/facility utilities, conduct re-validation when necessary.- Maintain process flowcharts, process risk evaluations/ and process input requirements for process equipment/facility utilities.- Maintain/update SOPs for process equipment/facility utilities using engineering change requests/orders.