Report to AP region for organization changeLeading all process and product validation in Dabao siteDevelopment C&S process in Dabao site.

Process development of new product introduction and process validationFormula updated for existing product and process updatedNew process introduced and evaluation of process change. Technical problem solving and issue investigation in plant

At that time, Dabao has been acquired by JNJ (Johnson and Johnson).Updating the quality system according to relative updated regulation and requirement from JNJ regional.Establish the Quality Manage System and the Quality Manual. Organize the compiling the procedure of production process. Edit the SOP and GMP document.Establish calibration plan of the instruments, edit the Validation Master Plan, and annual validation plan. Edit and check stability study protocol. Review the revalidation of the key- asepsis process , water system.Supply Auditor and internal auditor Prepare the audit annual plan and audit the supplier and follow up the Corrective Action from supplier. Confirm the effective of the action. Acceptance of the audit from regional and local SFDA.Quality management for new product and solving routing issueThe Quality management in the new product introduce and assure the new product to launch on the quality. Deal with the relative deviation and product destroy.

leave within qualifying period

1. Replied routine inspections from the BJDA, and update the information according to the regulation requirement. 2. Management of the instruments, the revalidation of the key-asepsis process, water system and HVAC system. The validation for the new equipments and new process. Evaluating something change, should be check the influence to quality and make some relative validation.3. Organize the compiling the procedure of production process. Finish the performance validation and cleaning process validation and aseptic processes revalidation.

Coordinator in project team for new facilityInstallation and running the equipment. Including the purify water system and WFI water system and fermenter system, compress air system and HVAC system, the downstream system and filling system. Validation of utility and process system.

1. The supervision and management of the construction including the fire fighting system, purify water system, steam system,power station,HAVC system, eletric system including power system and lighting system. 2. Assistant the communitcation about the plant design between the foreign expert and the local design institute. the design implementation between foreign expert and the local installation company.

Translate the technical document of new product and new design plant. File and manage these dossiers.