周海燕 Email and Phone Number

1) Leading plant to obtain Drug manufacturing License, Drug license and GMP license, such as Lab’s construction, stability test, application documents writing, procedures writing. Now, obtain 4 GMP licenses for 4 sub-companies, another 10 licenses are in process to be obtained.2)Open the door and built the relationship with target region local FDA3) Maintain the relationship with local FDA, CFDA, CDE where we are4) Help to explain and solve the problems during application and processes There are below regions which I concerns according the location of projects, such as Beijing, Tianjin, Shandong (Dongying, Qingdao, Rizhao), Guangzhou, Sichuan, Liaoning (Dalian, Shenyang), Shanghai, Jiangsu (Zhangjiagang, Huai’an), Anhui ( Hefei), Shanxi ( Linfen, Datong), Hebei (Cangzhou).5) Per-audit the plant before official inspection from FDA6) Assist plant to renewal Medical O2 license7) Annual audit to plants following GMP regulatory, write the audit report and tracking the solution for the problems8) Set up Air Liquide GMP model9) Optimize Analysis process and reduce the analysis time10) Deal with hospital complaint and Pharmacovigilance11) Make the strategy for new drug registration12）local PVG officerMedical Device Part 1) Renewal Medical device ( Class III and II) trading license2) Pre- audit the medical device subsidiary company before official inspection from FDA3) Make strategy for new device registration 4) Registration the new medical device with support of consultant

a) QC supervisor Writing weekly and monthly report, and analyzing recent products’ quality. Involved in the equipments modification, and validate the modified results. Deal with consumer complaint Solving the problems which QC finds on-line. Organizing weekly Quality meeting  Organizing monthly Marketing Review, analyzing the results, sending the report to relative departments b) AIB (Focus on Food Safety) project Leader Organize the AIB regulations Training every year Inspect the plants following AIB standards once per month, then make the monthly inspection report, and tracking the results. Coaching different departments to solve the problems which were found during inspection. c) Others Suppliers’ audit Audit the plant every half year following Pepsi international QA Manual Organize to write HACCP system, training relative employees. Inspect the plant following GMP procedure Organize the GMP training every year..