职责概要：



负责苏州工厂的生产以及公用系统区域的质量管理工作，包括日常监督管理，数据审核等。



岗位职责：



建立以及执行生产线质量管理体系, 生产现场的监控和合规管理；

负责生产相关的变更，偏差调查等的开展，协调以及跟进；

不定期巡视和检查生产现场, 辅助区域以及相关记录；

协调/组织GMP相关的培训；

参与生产物料和供应商的管控；

参与批记录的审核和产品的放行；

协助和参与内审以及外部审计。



任职资格：



大学本科及以上学历，医药及相关专业毕业；

2年及以上GMP质量相关的工作经验；

熟悉GMP等相关生物制品法律法规；

良好的组织、协调、沟通、计划和执行能力；

有责任心，能够承受挑战性的工作；

英语流利优先。







Job Summary:



The candidate will be responsible for line quality management in Suzhou site, including daily work and data review, etc.



Responsibility：



Establish and execute of the line quality management system, on site supervision and compliance control;

Responsible for conducting/coordinating/ tracking research related change/deviation investigation;

Site inspection in different time including reviewing documents;

Coordinate/manage GMP related trainings;

Involved in control of material and suppliers;

Involved in batch record review and the release of products;

Assist in self inspection/regulatory audit.



Qualification:



Bachelor’s degree or above, medicine or related major;

2 years or above quality working experience;

Familiar with GMP regulations for biological drugs;

Good organization, coordination, communication, planning and execution ability;

Responsible and able to complete challenging work;

Fluent English is a plus.