Xuexue (Sophie) Yang

Experience

• 

  GSK

  Mar 2012 - Sept 2019

  - Worked with external supply functions, Supplier Quality, External Technical Team, Procurement, Planning, etc to ensure the quality of the materials and APIs supplied.- Worked with external and internal teams to make sure the quality of outsourced API supplied.- Supplier change contorl, supplier incident, deviations, OOS, complaint management.- SME for Acceptance Based on Supplier's CoA and Travel Sample Management.- SME for Outsourced API Management, including batch release.- Annual product review and Quality agree ment, etc. Show less • Responsible for Technical Terms of Supply (TTS) Agreement between supplying company and receiving company;• Responsible to communication with LOCQ / QP;• Own site Quality Speak up System; Embed site Quality Culture;• Deal with Deviations to support batch release; Conduct QMS Gap Analysis;• Fully understand the process and participate the site inspection readiness;• Led OQA team to revisit on site GEMBA as OQA standard work;• Led Data Integrity Assessment against all the GxP systems; Embedded the global Data Integrity training to drive the concept change in site employees;• Supported to complete MHRA CAPA / Independent Review with the understanding of new regulatory guidelines and applies these to processes or plant as required;• Took responsibility for material and product risk assessment for site recovery after TEDA Explosion;• Deeper understand the business of end to end supply chain for global supplying site. Show less • Developed Albendaozle ColorFlex Method and Specification – Project Lead;• Performed site Process Tolerance Assessment – Project Lead;• Optimized BOM - Project Lead;• Implemented Product Performance Assessment (PPA, Data Trending) to Mitigate Deviations in Manufacturing Process – Project Lead;• Led site Technical Risk Assessment (TRA) for Tablet Products;• Led and participated tablet related and contamination RCA investigation for trouble shooting to support product release;• Provided support for the PPR through Data Analysis applied STATISTICA;• Provided routine support for the site in term of QMS implementation, updating of relevant SOP and response to regulatory or customer’s requests;• Provided support for site Quality and EHS tasks achieving;• Enhanced the Process understanding for the manufacturing processing including process robustness study, initiated process improvement and carried out trial and process validation;• Led the Material Assessment and the Material Sourcing Change Project;• Supported site Compliance assessment between internal documents and regulatory dossiers to achieve Project Edge target. Show less

  • Sr. Op/Validation QA Specialist

    Jul 2018 - Sept 2019

  • FLP Programme/Sr. Business QA Associate

    Aug 2017 - Jun 2018

  • FLP Programme/Supplier QA and QMS Officer

    Aug 2016 - Jul 2017

  • FLP Programme/Operational QA Specialist

    Jul 2015 - Jul 2016

  • Technical Engineer/Product Owner

    Jul 2013 - Jun 2015

  • Management Trainee/Engineer/Project Manager

    Mar 2012 - Jul 2013
• 

  Sanofi Pasteur

  Sept 2019 - Aug 2021

  Upstream Production Associate Manager

  Overall management of 3 production teams.