Experience

Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Manager

  • Jan 2015 - Present

  CMO QA manager - Quality oversight for CMO to make sure CMOs follow the quality system from Novartis; - Manage quality issues happened in CMO: Change control, Deviation, Complaints, OOS, and Recall etc. - QAA updated; - Audit for Suppliers and CMO and CAPA follow-up; - Coordinate the communication between CMO and all the related function of Novartis; CMO QA manager - Quality oversight for CMO to make sure CMOs follow the quality system from Novartis; - Manage quality issues happened in CMO: Change control, Deviation, Complaints, OOS, and Recall etc. - QAA updated; - Audit for Suppliers and CMO and CAPA follow-up; - Coordinate the communication between CMO and all the related function of Novartis;



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Supervisor

  • Jun 2014 - Jan 2015

  Lead team members work on deviation, complaint, OOS, return, recall, batch release, solve any issues on product related quality, keep the product complied with cGMP.

• QA Specialist

  • Jun 2011 - Jun 2014

  Product scope: Pharma(Oral liquid, tablets, ampoule, capsule)- Deviation, OOS, Complaint handling- on site GMP compliance- Delegate QP- serialization code



Zhejiang Goldpharma Co., Ltd.(Chemo Spain)

• Taizhou, Zhejiang, China

• QA Supervisor

  • Aug 2007 - Jun 2011

  Production scope: API - Production technical transfer and new product lunch; - Regular Affair(submit API EU DMF and USA DMF ); - Quality system: customer audit, validation, change control, deviation, OOS supplier management GMP compliance ect. Production scope: API - Production technical transfer and new product lunch; - Regular Affair(submit API EU DMF and USA DMF ); - Quality system: customer audit, validation, change control, deviation, OOS supplier management GMP compliance ect.