Samuel Soon
Quality Assurance
Singapore,Singapore
Summary
Thorough Quality Assurance Specialist with 16 years background in Drug Manufacturing. Excellent resource management and allocation skills. Outstanding communication and organizational talents. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.
Overview
16
16
years of professional experience
Work History
Quality Assurance Specialist
BioNTech Pharmaceuticals Asia Pacific Pte Ltd
07.2024 - Current
- Establish QMS system for Deviation and CAPA in Veeva
- Establish and create Deviation and CAPA process and procedures
- Establish and create Document Archival business process and procedures
Quality Assurance Senior Associate
Amgen Singapore Manufacturing Pte Ltd
02.2022 - 06.2024
- Provided monthly updates to site leadership on quality metrics. Follow up on red metrices and ensured on track completion.
- Analyzed quality and performance data to support issue prevention and improvement efforts. Resulted in controlled data with overall reduction in deviation.
- Site SME, Trainer and coach of Deviation process and investigational tools. Conducted training for multi-regional staff.
- Site SME and coach of Document Management and GDocP process.
- Lead cross-functional, multi-regional team to roll out companywide process alignment.
- Representative of Singapore in Multi-regional network for Deviation and CAPA, Document Management System and GDocP.
Plant Quality Senior Associate
Amgen Singapore Manufacturing Pte Ltd
05.2016 - 02.2022
- Supported in start-up of API small molecule manufacturing plant.
- Establish business process between QA and other functions.
- Provide QA oversight on GMP processes for various functions.
- QA review of Change Control and Deviation for various functions.
- Assign change control records to team.
- Trained and supported new team members, maintaining culture of collaboration.
Quality Assurance Specialist
Roche Singapore Technical Operations Pte Ltd
09.2011 - 05.2016
- Provide QA oversight on GMP processes for various functions.
- Establish business process between QA and QC.
- Trained and supported new team members, maintaining culture of collaboration.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
- Reviewed production processes and identified potential quality issues.
Senior QC Technician
Roche Singapore Technical Operations Pte Ltd
08.2008 - 09.2011
- Supported in qualification of manufacturing plant and QC lab.
- Coordinate daily task to team.
- Lead in excursion investigation.
- Trainer and owner of Environmental and Water monitoring Process.
- Liaise with cross-functional and external vendor on lab related discussion.
Education
Bachelor of Science - Biomedical Sciences
Diploma in Biomedical Science - Pharmaceutical Sciences
Skills
- Project Management
- Collaboration skills
- Data Analysis
- Analytical Thinking
- Problem-solving skills
- Performance monitoring
- Risk Management
- Public Speaking
- Quality Assurance
- Quality Management Systems
Accomplishments
- Collaborated with multi-regional team in the deviation process improvement. Resulted in 50% reduction in manhour for Singapore.
- Drive and collaborated with cross functions and successfully reduce total number of deviations by 20%.
- Leader of Global cross functional team on process improvement initiative. Successfully align and implemented the changes that is rolled out company wide.
- QA contact for multiple major testing and Manufacturing software updates. Successfully completed updates with minor impact to operation.
- Implemented various business processes between QA and other functions. e.g. QC Deviation management process, Site Pest Control reporting process, Utilities alarm reporting process.
Timeline
Quality Assurance Specialist - BioNTech Pharmaceuticals Asia Pacific Pte Ltd
07.2024 - Current
Quality Assurance Senior Associate - Amgen Singapore Manufacturing Pte Ltd
02.2022 - 06.2024
Plant Quality Senior Associate - Amgen Singapore Manufacturing Pte Ltd
05.2016 - 02.2022
Quality Assurance Specialist - Roche Singapore Technical Operations Pte Ltd
09.2011 - 05.2016
Senior QC Technician - Roche Singapore Technical Operations Pte Ltd
08.2008 - 09.2011
Central Queensland University - Bachelor of Science, Biomedical Sciences
Republic Polytechnic - Diploma in Biomedical Science, Pharmaceutical Sciences
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