At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

全面负责进口产品的质量监控，确保运作过程和产品得到有效控制，并符合所有适用的GMP/GSP标准和公司GQS的要求；定期进行审计以确定整个系统符合要求；并要求对审计过程存在问题或缺陷提出改进意见。

The purpose of this QA manager role is to have quality oversight to FTZ operation to determine that systems, facilities and written procedures are in compliance with GMP/GSP and Lilly global quality standards and followed in order to assure that operations are in control and products meet, throughout the whole processes, all the applicable specifications. Periodic audits are conducted with the operations against applicable regulations and Lilly standards to determine that procedures and systems are suitable to oversight of operations and action plans required to address observations resulted from audit.

Primary Responsibilities:    

1 保证质量体系符合礼来GQS及相关法律/法规的要求，确保对产品的任何操作均不影响产品的 质量。

To ensure local Quality System for Lilly China Marketing Affiliate is compliance with the   requirements of Lilly GQS and local regulations, and be sure there is no impact on Product Quality.

2 负责对礼来的进口产品进库检查 和放行。

To be responsible for product verification and release on incoming products in bonded warehouse.

3 负责处理 促销材料的管理

To be responsible for promotional material management.

4 负责公司进口相关的GSP服务商的监督管理, 并确保其使用的仓库和温湿度监控系统等符合验证要求。

To be responsible for imported related GSP Service Providers quality management， ensuring the qualification of warehouses and temperature monitoring system can meet the requirements.

5作为文件系统Affiliate 相关文件的文件控制人，维护良好的质量文件系统。

As the main Document Controller (DC)for Affiliate related documents, maintain good documentation system.

6负责进行进口产品相关的偏差 调查和处理及变更管理, 符合GQS。

 To be responsible for conducting the investigation and handling of deviation related to the Imported product， and change control to meets the requirements of GQS.

7 负责产品的定制，准备/更新和维护相应的主包装命令、标准包装指令

To be responsible for product customization, prepare and update and maintain Packaging Order, SPI, etc. 

8 负责医师样品相关的质量活动和质量管理

To be responsible for physician sample related quality activities and oversight.

9 负责供应商的月度质量报表及定期现场审核或评估。

To be responsible for prepare monthly relevant service provider Metrics and  periodic on-site    assessment on providers .

Minimum Qualification Requirements:   

1本科或以上学历，药学，化学或相关专业  Bachelor degree or above, majored in pharmaceuticals, chemistry  or related sciences

2至少3年的药品质量管理QA经验和GSP知识 Three years of QA experience in drug product distribution/ wholesaler and GSP knowledge.  

3 能用英语说，写和读  Capable of listening, speaking and  writing  in English in fluency

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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