Sr.Qa Specialist
Current1.To Manage shiftQA team, such as: training shift QAs for using SAP&PMX&CAPA system, routine oversight, abnormal event addressing, support validation actives etc., It is the most important is to deliver high quality sense/knowledge/behavior to people who involved GMP activities. Meanwhile, our team help business to make sure business process is smooth going. Besides, I am involved Process Team as quality representative to provide quality support to achieve business target.2.Be familiar with… Show more 1.To Manage shiftQA team, such as: training shift QAs for using SAP&PMX&CAPA system, routine oversight, abnormal event addressing, support validation actives etc., It is the most important is to deliver high quality sense/knowledge/behavior to people who involved GMP activities. Meanwhile, our team help business to make sure business process is smooth going. Besides, I am involved Process Team as quality representative to provide quality support to achieve business target.2.Be familiar with products process (sachet suspensions, tablet and capsule) , ability to review Qualification and Validation documents.3.Support batch release.4.Take CSQA responsibility to oversight CS system, to improve CS practices/documents/system to meet requirements of Lilly LQP and Part11.5.To address changes and deviations through Lilly TrackWise(CAPA)system. During deviation investigation, ability to strong communication with lead investigator to ensure investigation report meets requirements of logical, scientific and reasonable. For change process, to make appropriate change classification/impact analysis according to requirements of Lilly Global GQS, China GMP.6.To support PMX MES project (E-dispensing) as quality representative to ensure all process is consistence with Lilly GQS&CQP and China GMP requirements. Based on E-dispensing successful go-Live, so be awarded Gold Star employee.7.To support GB/BB project, such as: educe Granulation Cycle Time, Reduce Dispensing Cycle Time, PVP (Procedure Vs Practices)8.To support Global Audit, China Audit and Sit Self Inspection. Show less