Shao-Yu Li - QA Manager

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Shao-yu li

New Taipei City, New Taipei City, Taiwan

+91 xxxx xxxxx

[email protected]

24 followers

Timeline
Nov 2011 - Apr 2013
Regulatory Affairs Specialist
Taidoc Technology Corp.
Jun 2013 - Nov 2013
Research Assistant
National Synchrotron Radiation Research Center
Aug 2014 - Apr 2016
Product Division Deputy Director
Lihpao Life Science Corp.
Current Company
Aug 2016 - now
Quality Assurance Specialist
Sysmex Corporation
About me
QA Manager
Education
- National taipei university of education
  2004 - 2008
  Bachelor of science (b.s.) science education (biology and chemistry) 85.9
  Majored in Biology and ChemistryElectived Earth Science and Physics
- National chung hsing university
  2009 - 2011
  Master of science (m.s.) life science 89.8
  Topic：Study on the specific inhibitors of human m-NAD(P)+-ME
Experience
- Taidoc technology corp.
  Nov 2011 - Apr 2013
  Regulatory affairs specialist
  - QSD application- Product registration to TFDA and CFDA - Technical documents writing
- National synchrotron radiation research center
  Jun 2013 - Nov 2013
  Research assistant
  - Protein crystallography experimental station maintenance. - Protein crystallization and structure analysis
- Lihpao life science corp.
  Aug 2014 - Apr 2016
  Product division deputy director
  - Developed regulatory strategies and timeline for product development.- Provided guidance on regulatory compliance.- Supervised the IVD kit manufacturing and improved the process.- Managed and prepared the applications of GMP and ISO13485 for IVD kit.- Developed DNA vaccine with lactobacillus shuttle vector.
- Sysmex corporation
  Aug 2016 - now
  Quality assurance specialist
Licenses & Certifications
- Gept (high- intermediate)
  The language training & testing center
  Feb 2009
  View certificate