Experience

盈健醫療 Human Health

• Hong Kong
• Hospitals and Health Care
• 1 - 100 Employee

• Operations Manager

  • Jun 2018 - Present

  - Lead and Motivate the Business operations in the Specialist Medical Team, Imaging and Health Check Center Team and Day Procedures Center Team on achieving company goals with high service quality - Design Operations Flow by fulfilling Law & Policy and industrial good practice to uplift operations efficiency- Formulate training and auditing loops to drive continuous optimisation- Liase with internal and external parties for smooth operations and gaining mutual benefits- Develop business strategies to activate the needs in target customers and deliver exceptional client journey - Communicate and coordinate with government and other corporate to implement health related services- Lead and participate in projects and to achieve goals and missions in teams



China Regenerative Medicine International

• Hong Kong
• Biotechnology
• 1 - 100 Employee

• Quality Assurance Director

  • Aug 2016 - Jan 2018

  • Design and Manage the development of Advanced Therapy Manufacturing Cleanrooms (Grade A to Grade D) according to GMP PIC/S, ISO9001, ISO14644 and ISO14698• Establish and execute policies and procedures to smooth out the productions, warehouse and logistics operations processes for the Anti-aging and Regenerative Products to support sales forecast• Formulate training programs and plans and conduct trainings for internal staffs and external business partners in order to provide aligned service experiences and produce product quality with regulatory expectation and organization objectives • Evaluate, Select, and Manage Vendor Bases by on-site audits (China and Hong Kong), product quality evaluations and risk assessment• Work with Hong Kong Department of Health, Australia TGA and International Regulatory bodies for PIC/S GMP licenses for the manufacturing facilities• Handle complaints and recommendations and execute CAPA analysis to continuously improve the operations processes, service experiences and product quality• New Product design and Technical translation from Academics Research to GMP Manufacturing, Manufacturing process development, Analytical Method Development and Environmental control, Warehouse and Logistics Development for regenerative products• Manage a twenty people team in the operations and QA team by controlling budgets, materials and resources, and managing the operations performance.



DKSH

• Switzerland
• Professional Services
• 700 & Above Employee

• Assistant Manager, VAS operations

  • Mar 2015 - Aug 2016

  • Design and Manage the Manufacturing Facility for Secondary Packaging Manufacturer for Pharmaceutical Products according to GMP PIC/S and ISO9001.• Establish and execute policies and procedures to smooth out the productions, warehouse and logistics operations processes for Western Pharmaceutical Products to support sales forecast• Formulate training programs and plans and conduct trainings for internal staffs and external business partners in order to provide aligned service experiences and produce product quality with regulatory expectation and organization objectives • Successfully register the facility with PIC/S GMP at Hong Kong Department of Health• Evaluate, Select, and Manage Vendor Bases by on-site audits (Taiwan, China and Hong Kong), product quality evaluations and risk assessment• Protocol establishment and implementation for Facility environmental qualification, Equipment qualification, Process Validation and Product Quality Monitoring Program• Handle complaints and recommendations and execute CAPA analysis to continuously improve the operations processes, service experiences and product quality• Provide Client Management and Services for business expansion and problems solving solutions• Manage a twenty people team in the operations team by controlling budgets, materials and resources, and managing the operations performance.



Asana Supply Limited

• Assistant Quality Assurance Manager

  • Sep 2012 - Feb 2015

  • Design and Manage the development of Manufacturing Facility for cosmetics and health supplement products according to ISO9001 and GMP• Establish and execute policies and procedures to smooth out the productions, warehouse and logistics operations processes for the Cosmetics and Health Supplement Products to support sales forecast• Formulate training programs and plans and conduct trainings for internal staffs and external business partners in order to provide aligned service experiences and produce product quality with regulatory expectation and organization objectives • New Product design and Technical translation from Research to Mass Productions for cosmetics and health supplement products• Evaluate, Select, and Manage Vendor Bases by on-site audits (Korea, Taiwan, China and Hong Kong), product quality evaluations and risk assessment• Protocol establishment and implementation for Facility environmental qualification, Equipment qualification, Process Validation and Product Quality Monitoring Program• Handle complaints and recommendations and execute CAPA analysis to continuously improve the operations processes, service experiences and product quality• Provide Client Management and Services for business expansion and problems solving solutions• Manage a ten people team in the QA and QC team by controlling budgets, materials and resources, and managing the operations performance.



Hong Kong Quality Assurance Agency

• Senior Project Officer

  • Jul 2011 - Sep 2012

  • Setup, implement and register the certification service (ISO9001, HACCP, SA8000, OSH, etc…) with the certification body quality system: ISO17021:2011 at Hong Kong Accreditation Service (hereunder named as HKAS) and oversea regulatory bodies (i.e. UKAS, CNAS, ANAB)• Handle complaints and recommendations and execute CAPA analysis to continuously improve the operations processes, service experiences and product quality• Perform internal audits to control management systems implementation• Act as auditor (team member) for business in Hong Kong• Attend HKAS meeting and act as key certification body representative to provide comments and feedbacks for ISO17021:2011 revision• Participate in local and international seminars, forums, meetings and trainings to build up and maintain international partnership with accreditation bodies and other certification bodies



Cell Therapy Technologies Centre Limited

• Quality Assurance Manager

  • Nov 2007 - Apr 2011

  • Design and Manage the development of laboratory for cellular therapy product and medical testing laboratory according to ISO9001, ISO15189 and AABB CT Standard.• Establish and execute policies and procedures to smooth out the productions, warehouse and logistics operations processes for the cellular therapy product to support sales forecast.• Evaluate, Select, and Manage Vendor Bases by on-site audits (Hong Kong), product quality evaluations and risk assessment• Formulate training programs and plans and conduct trainings for internal staffs and external business partners in order to provide aligned service experiences and produce product quality with regulatory expectation and organization objectives • Protocol establishment and implementation for Facility environmental qualification, Equipment qualification, Process Validation and Product Quality Monitoring Program• Handle complaints and recommendations and execute CAPA analysis to continuously improve the operations processes, service experiences and product quality• Successfully complete an FDA approved Clinical Trial by using Haematopoietic Stem Cells for Cerebral Palsy at USA Duke University• Manage a five people team in the QA team by controlling budgets, materials and resources, and managing the operations performance.