 Project management Organize ,coordinate and review concept design, detailed design. Organize and coordinate Project bidding. Organize and coordinate equipment procurement. Recruit people. Project cost control. Manage project quality, project progress and project change management, ensure the project construction carried out in accordance with the schedule, cost and quality requirements.the project has been completed on the end of March 2014. Quality management system set upWe have established preliminarily quality system in accordance with EUGMP requirement under the assistance of QP who is hired from the British, Now in continuously improve; Validation management.We established a validation system according to EUGMP requirements ,We have completed all PQ of equipments and system and aseptic process simulation validation so far, from July to September, we will execute process validation and cleaning validation,At that time the project construction will be finished completely.

 Review quality management system and ensure QMS comply with SFDA GMP requirements. Coordinate internal audit and raw material and packaging material supplier audit and review audit report. Participate in deviation investigation and review deviation investigation report. Review validation master plan and validation protocol and report. Participate in CFDA GMP inspection. GMP training.This work finished and they got GMP certificate from SFDA in Feb 2013.

 Set up quality system according to cGMP and headquarters’ quality policy requirements, perform gap analysis reports, establish action plan and follow up until gaps closed, guarantee the quality system comply with cGMP requirements. Set up QC laboratory. Organize internal audit as required and and follow up until the findings were closed, and improve the GMP management. Implement GMP compliance against global GMP standards and China GMP requirement, By maintaining existing quality management system to ensure quality system operations in site meets the current regulatory. Evaluate the deviation and mistakes happened during production. Organize and coordinate the validation according to the site master validation plan and easure the validation comply with GMP requirement. GMP and related law training.

 Review BMR.  Release raw materials、packaging materials and intermediate.  Organize annual product quality trend analysis.  Organize deviation investigation and follow up CAPA results.  Change control management. Organize quality risk assessment. Organize and execute internal audit according to annual plan. Organize and coordinate validation implement in accordance with validation master plan for a new plant. Perform raw materials and packaging materials supplier audit.During this period, fully participate in the construction of new factories and set up a new factory quality management system, organize the new plant validation work.

 Optimize production process. Production department daily work management.  Training.

 Set up quality system according to cGMP and headquarters’ quality policy requirements, guarantee the quality system comply with cGMP requirements. Set up QC laboratory Organize internal audit. Handle deviation and mistakes happened during production Organize and coordinate the validation according to the site master validation  GMP and related law training  handle of customer complaints. Organize and execute raw materials and packaging materials supplier audit .

 Set up QC management documentation like OOS, OOT etc. Qc analyst test skill training QC daily work management Test method qualification.