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 Practices”.2. Partner with other departments to ensure compliance with national & international standards & legislation & collaborate with Global Leaders of Supplier Development, Design Controls, Regulatory Affairs, Clinical Affairs, & Legal to provide regulatory training, guidance & controls to the commercial, R&D & Engineering organizations.3. Provide necessary training tools & techniques to others to achieve quality practices & advice on changes & implementation of Quality Systems.Accomplishment:1. Successfully achieved ISO13485:2016 & MDSAP Certifications for Singapore site with Zero Findings.2. Successfully Setup Quality Improvement Process Change Management Communication Framework & Structure to handle Global Quality Leadership Council roll out QMS documents in order for Singapore SMEs to participant on Global Documents for better collaboration control and more efficient to reduce waiting &/or down time3. Successfully Setup & managed Singapore Obeya Room to handle Global Quality Improvement Plans & Change Control Management Administrative activities4. Successfully Setup, Implemented & Maintained Quality Compliance Department Functions & Roles to handle QMS, Certification/Customer/Internal/Product Safety/Global Internal/Qualification of Distributor Audits, Quality Events, Site Validation, Risk Management, Training & Development Management and Enterprise Change Management.5. Successfully sponsor Singapore Site Engineering Change Control Requests (ERs) RIE events to improve Singapore Site ER Turn Around Time (TAT) as well improve efficiency.6. Support in Global Corporate MDSAP Audit

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 regulations included:1. Identify, develop & deliver Global eQMS (framework, structure & processes), Regional Quality Plan, Regional Healthcare Facility Standard Modals, Validation Master Plan Standard Modals & customized Quality Plan to handle individual customer’s requirements.2. Provide leadership, coaching & operational management to Quality Managers to enable Supply Chain related activities are timely managed & meeting Regulations requirements.3. Identify & develop Qualification & Certification program to close staff competency gaps.Accomplishment:1. Successfully managed & resolved the Construction and Technical Gaps including redesign & provide technical guides & solution to Cold Chain Main Contractor to achieve the Working & Control Ranges of Cold Chain specification - Cold Room (2°C – 8°C), Freezer (-15°C to -30°C) for Toll City Healthcare Cold Chain Facility to meet GDPMDS & GDP requirements.2. Successfully validated Toll City Healthcare Temperature & Humidity Control Warehouse Facility, Cold Chain Facility & electronic Environmental Monitoring Systems.3. Successfully obtained Certifications for new site:a. GDPMDS with Zero Non Conformityb. GDP Certification for Therapeutic Products & Clinical Research Materialsc. CPM GDP Certification for Chinese Proprietary Medicines (CPM) & Clinical Research Materials4. Successfully obtained Licenses for new site:a. Medical Devices Manufacturing license (2 sites)b. Medical Devices Importer's & Wholesaler’s Licensesc. Therapeutic Products Importer's & Wholesale Licensesd. CPM Wholesale License

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 to handle Singapore Regulatory, Licenses, Approval and Permits including importation of Drug/Poison.Achievement/Accomplishment:Successfully achieved & maintained ISO 9001, ISO 13485, EC Certification & 2015 Recertification for Singapore plant with Zero Non Conformity.Successfully obtained Importer Licence & Wholesaler Licence from HSA in order to import Class B, C & D Medical Devices & legally to sell in Singapore.Successfully updated all Registered Product Licences, Dealer Licences & Product Owner current particulars with HSA.Successfully Setup eLHR network structure to reduce down time.Successfully developed & implemented formulation control to manage and control QA/QC Man Power requirements & value added process activities.Successfully developed, implemented & maintained Supplier Management/Contract Manufacturer Management included drafting Supplier/Contract Manufacturer Quality Agreement, Supplier & RM Qualification to reduce incoming inspection activities, Site Inspection Release Note, Return to Vendor Form, Supplier/Contract Manufacturer Monitoring & Evaluation Program but not limited to Site Audit & Calibration Report review procedures to streamline process for better control of process & remove non value added process.Successfully obtained GN-27 Special Approval from HSA to import & sale of Glider PTCA Balloon Catheters.Successful developed & conducted Annual Quality System Awareness Training Presentation Slide for year 2014/2015.Support and coordinate in Corporate Financial Audit, Process & Product Validation, Singapore Marketing Brochure, PCR Expo Exhibition Booth Setup.

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 Medical Devices.Global Involvement and Achievement/Accomplishment:Successfully setup War Room & handle US FDA Inspections for group companies,Successfully achieved and maintained ISO 9001, ISO 13485 and EC Certification and Recertification and also US FDA Facility Re-Registration for group companies,Conducted Gap Assessments on group companies Quality Systems Documentation and successfully resolved Legacy Gap issues for group companies,Successfully developed and implemented cost saving program for group companies.Successfully developed, structured, monitored & maintained Global/Group Emails Structure for better & time savings on inter communication and Global/Group Servers for group of companies Quality Systems documentation & records.Single developed & implemented US FDA 21 CFR part 820 QSR & related regulations compliance documentation for Clearlab US, Inc in 2 months.Appointed as Management Representative for Clearlab Group Companies to develop, monitor, implement & maintain the group companies Quality Systems.Successfully developed, implemented, monitored, and maintained Global Quality System Procedures, but not limited to Quality Management & Risk Management Systems, Global Trade Marks Registration & Renewal system, Central Document Control & Library, Artwork Control Systems, Global CAPA, Own Brand Labeling, Private Brand Labeling, Product Registration Monitoring & Maintaining System and respective country Medical Device Reporting SOPs for group companies.Provide guides & technical support on standards and regulations requirements for New SiHy Product Development & Lens Care Solutions Development.

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 program, Supplier Audit Program schedule & activities.To update ISO International Standards & US FDA Regulatory requirements for Medical Devices.To liaise with Global Regulatory Affairs/Quality Systems in any matters related to Regulatory Affairs/Quality Systems & External Auditors/Inspectors (ISO/US FDA).To organize & monitor Management Review activities are conducted.To ensure that Corporate Policies, Novartis HSE Policy & National HSE Standards are implemented & respected.Global Involvement, Achievement/Accomplishment:Selected as Asia Pacific Representative to develop Global SOPs.Successfully developed Global NCR, OOS/OOT, Deviation and CAPA SOPs, Global Calibration SOP and Global Preventive Maintenance SOP, Global SOPs for Internal Auditing, Supplier Management, Global Complaint Management System.Appointed as CIBA Vision Global QS Representative to assist appointed China 3rd Party Contractor for Repackaging, Re-labeling & Distribution of Lens Care Products & Contact Lens Products, to design & develop Quality Systems also to validate applicable Production Lines for Repackaging, Re-labeling & Distribution of Lens Care Products & Contact Lens Products related activities. Successfully completed the Project in 4.5 months.Successfully closed Packaging Integrity – Delamination Process Improvement Project.Successfully developed and maintained Supplier Management program.Participant in Setup of New Air Optix Upgrade 6pks project & Nitro Project.Managed Pre FDA Inspection preparation & mock up audit activities & War Room activities during US FDA Inspection.Sponsor Gold Belt Project.