Aileen ZHU/朱红
QRA Director/全国质量法规总监
Cardinal Health China/康德乐医药
Experience:
Ø More than 20 years work experience in Pharma Manufacturer and Distribution center.Familiar with GMP/GDP/GSP requirements and China regulations from CFDA, Custom, CCIQ etc.
多年的药品生产企业,药品流通企业工作经历,熟悉医药产品供应链、营运、GMP和GDP,GSP,ISO的管理,熟悉中国食品药品监督管理,卫生,海关,商检相关药品等医药产品法规。
Ø Be familiar with QRM in Pharma distributor and provide the complete solution on quality regulatory compliance .
熟悉医药流通企业的质量风险管理,降低药品流通风险。为业务发展提供完善的质量法规解决方案。
Ø Be familiar with oversea pharma related guidelines and quality requirements from MNC, understand well on the integration process on new product lead in China market.
熟悉海外相关医药法规指南和跨国药厂的质量要求,了解海外产品引入中国市场的整合流程。
Ø Achieve a lot of experiences on Pharma business and operation compliance management.
对公司业务和营运的合规管理积累了丰富的经验。