Experience

3SBio Inc.

• China
• Biotechnology Research
• 1 - 100 Employee

• Project Manager

  • Mar 2022 - Present

  Project manager for a biological product filing BLA in FDA

• Compliance Supervisor

  • Apr 2020 - Mar 2022

  1. Regulations compliance: NMPA, ICH, PIC/S, EU, FDA.2. Guidance for industry, PDA technical reports, international standards compliance, FDA 483 and warning letter review, quality continuously improvement.3. Project manager for Y2024 FDA BLA inspection readiness, support for CMC projects for US and EU market.4. Ownership of self inspection system, coordinate consulting company inspections.5. Coordinate regulators and customer inspections(domestic and overseas).6. Support in management review.7. Train for GMP related course and continuously improve quality awareness.8. Providing compliance support to decision makers, including cross references to industry guidelines and best practices. Show less



FrieslandCampina

• Netherlands
• Food and Beverage Manufacturing
• 700 & Above Employee

• QA

  • Dec 2017 - Mar 2020

  1.Regional Supplier Quality Management Greater China, direct reporting to headquarter QA manager in the Netherlands. Lead auditor based on corporate standard. 2.Validation. 3.Site QMS. Owner of change control system. Use risk analysis tools, involve in global change projects. Internal audits, management review, etc. 4.Specification management together with corporate R&D, draft quality monitoring plans for raw material. 1.Regional Supplier Quality Management Greater China, direct reporting to headquarter QA manager in the Netherlands. Lead auditor based on corporate standard. 2.Validation. 3.Site QMS. Owner of change control system. Use risk analysis tools, involve in global change projects. Internal audits, management review, etc. 4.Specification management together with corporate R&D, draft quality monitoring plans for raw material.



Eisai US

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Production Supervisor

  • Aug 2017 - Sep 2017

  Managing two SOD workshops. Managing two SOD workshops.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Technician/Engineer

  • Apr 2016 - Jul 2017

  Risk assessments, equipment qualification, process validation, cleaning validation. 2017.04 Promoted to validation engineer. Risk assessments, equipment qualification, process validation, cleaning validation. 2017.04 Promoted to validation engineer.