ong yee choong

During my career I have been exposed to many aspects of manufacturing process, packaging, life cycle projects, branding and repacking changes, process improvement, non-conformance investigation, change request process, technical transfer and validation of bulk pharmaceutical (API) tableting and contact lenses. 

I have developed a wide range of skills and responsibilities and accomplished the following:

1.New plants and facilities set-up. Led in setting up of 5 new plant start-ups and commissioning:

• 2 API Pharmaceutical plant 
• 1 Tableting Facility
• 1 Medical Device facilities
• Third party contact re-packer to repack global Alcon contact lenses and supply to worldwide

2 Lifecycle Projects

• Led the supply-related evaluation and the implementation of Lifecycle projects to ensure uninterrupted supply during the execution phase considering regulatory, production operations, commercial forecasts and other relevant x-functional impacts
• Coordinated the activities and aligned involved stakeholders from different functions such as master data and graphics to ensure a timely implementation of lifecycle projects such as product launches
• Led and coordinated global change request for branding, artwork changes and introduction of new packaging graphics

3.Machine , material supplier qualifications and validation

• Led in setting up of automated production equipment and packaging equipment 
• Led in qualifying of raw material and packaging components suppliers 
  
   

3.Computerized system

• Successful implementation of SAP for PLTP in AML in 2010 and SAP IRIS in 2019
• Successful implementation of MES system for Production and Quality in AML in 2011
• Leading the IRIS SAP implementation for Supply Chain Module (SCM) and successfully go live or implemented on 01 Jan 2023.

4.Regulatory audit

• Successful audit by regulatory agencies from FDA for new product launches, TGA, BSI (ISO13485) and Health Authorities 

• Familiar and trained in:
  • Production operations, planning, inventory control, logistics and equipment maintenance 
  • Equipment installation and qualification of automated equipment 
  • GMP, GDP,  Health Safety Environment (HSE) practices and Emergency Response Team
  • Distributed Control System (DCS), production management, supervision, SAP and Manufacturing Execution System (MES)
    
     
• Trained and certified:
  • Lean Six Sigma Silver Belt 
  • Leading global projects and Change Request (CR) 
  • MDSAP & ISO 13485 Internal Auditor
  • Non-conformance investigator and approver
  • Planning & Managing Project
  • Failure Mode Effect Analysis (FMEA)
  • Problem Solving Skill(KT)
  • Supervisory Leadership and Development Program
  • Pharmaceutical Technology 
  • Industry trainer, developed OJT blue print and conducted OJT training
    
     

Master In Business Administration