Simon Sim Email & Phone Number

Singapore

Singapore

Develop & implement of Illumina QMS & quality activities, to ensure operational excellence is maintained across all elements of product development, manufacturing distribution & on market support and to meet Regulations Requirements:1. Lead quality systems & serve as site champion towards quality improvement initiatives. Identifies and shares “Best.

Singapore

Developing & implementing regional Toll Healthcare’s Quality, Compliance & Regulatory Affairs Supply Chain frameworks, strategies, policies, priorities & standardize business processes to ensure all activities are complied with GDP, GDPMDS, GMP, ISO, GHTF, EC, US FDA Standards & Regulations, Directives for Medical Devices, Pharmacopeia Standards, country.

Managing Singapore Plant Quality Department to ensure all activities are complied to ISO, GHTF, EC, US FDA Standards & Regulations, MDD (Directives for Medical Devices) for CE Marking & Singapore HSA (Health Science Authority, Singapore) Regulations and Compliance Requirements.Appointed as Singapore Plant Management Representative & HSA CRIS Administrator.

Group Corporate Office, Singapore

Managing Regulatory Affairs and Compliance Department for Singapore, Korea and USA Plant to meet all related Country Regulations and Compliance Requirements for either Product Registration or Product Certification and also to ensure all plants are complied with related ISO, GHTF, EC and US FDA International Standards or Regulations or Directives for.

Batam, Indonesia

To manage Quality Department to comply to ISO/FDA International Standard Medical Devices, CAPA, Audit, Complaint Handling, Nonconformance, Design/Process Change Control Compliance and Document Change Control Compliance activities.To setup annual Quality KPI.To identify, lead & monitor Quality Improvement Projects & Programs.To manage Internal Quality Audit.