Experience

中美天津史克制药有限公司

• 1 - 100 Employee

• Technical Manager

  • Mar 2019 - Present

  Team ManagementPerformance ManagementProduct Technical TransferProduct Life cycle Management

• Senior Technical Engineer

  • Jun 2018 - Mar 2019

  Overall look after capsule product. Problem solving.Ensure Process robustness. Data trending. Periodic Product Review.

• Technical Engineer

  • Apr 2015 - Jun 2018

  1.Maintenance for commercialized products at high process capability, trouble shooting.(Capsules)2.Lead sourcing change implementation to ensure high-quality project delivery on time through cross function cooperation and proper project management skills.Key words:Non-production time/Cost/Material risk assessment/change control/Process Validation protocol/product releasing/project management.3.Key Equipment qualificationParticipate in equipment design and selection, team got Gold Award recognized by China Region after project completion.Familiar with capsule filling machine rationale, lead new equipment trial and validation; Familiar with FBD equipment and process.Know about basic tablet process and key manufacturing equipment mechanism.4.Product Life-cycle Management CoordinatorLocalized for global PLM Process.PLM concept promotion (3 stages), technical risk assessment capability recognized by central team (6 steps).Hosting for monthly data trending meeting, which is used for abnormal trending identification, working out mitigation plans before it becomes a real deviation. This is to keep products stable.Process capability at site is in the leading position across region. Recognized by central team. Show less

• Computer System Validation Engineer

  • Aug 2011 - Mar 2015

  - To support Computer System Project to meet site and regulatory expectation. (IT system)- Responsible for site training, to improve site Compliance awareness

• Change Control Expert

  • Aug 2011 - Aug 2013

  Site Change Control Process Owner