1. Responsible for building quality system of new OSD factory, organize and draft the quality documents, and make execution plan;2. Review all the quality documents;3. Train the staff about GMP and other regulations;4. Draft the validation master plan, and guide the room verification, purified water system qualification, HVAC system qualification, equipments qualification, product process validation and cleaning validation .ect;5. Suppliers management, organize the suppliers quality assessment and audit;6. Draft the raw materials, packaging materials, in-process product and finished product specification,(include CP and USP level);7. Organize internal self-inspection and participate in external GMP inspection;8. Deviation management, investigate deviations, risk assessment and CAPA review;9. Change control management, review changes, evaluate effectiveness;10. Participate in evaluating new product, collect the NDAs information on US market(include API information and DMF status, excipient information, packaging information, BE guidance, dissolution profile, patents and other ANDAs holders information);11. Participate in product scale-up and exhibited batches manufacturing.12. Manage routine affairs of QA department.Achievement: Completed construction of quality system of new factory, kept qualification of HVAC system, Purified water system and equipment, process validation on the schedule. Got local GMP approval on Jan, 2015.

Responsibilities：1. Manage the suppliers, ensure the API, Excipients, Packaging Material used in product complies with the local GMP and EU GMP, take charge of supplier audit. 2. Manage Change Controls and deviations. 3. Handle and monitor complaints from customers and contract giver . 4. In charge of CAPA follow up, tracing of updated BP and EP. 5. Draft the raw materials specification and finished product specification, generate quality SOPs and review other updated SOPs. 6. Draft the VMP, SMF and product quality review. 7. Investigate the OOS until it is closed. 8. Review the Batch manufacturing record and release the product of Perrigo UK to EU market. 9. Charge of communication with quality and technical person from Perrigo UK in English, participate in official audit ( Chinese FDA, MHRA) and customer audit. 10. Participate in self-inspection.Achievement：1 Experienced UK MHRA inspection as a key person in MAY, 2011 and August, 2013, passed the inspections with no critical and major deficiency.2. Experienced Chinese GMP (2010) audit in April,2013, got no major and critical deficiency.