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Compliance QA Engineer /Specialist

Location Wuxi, Jiangsu, China Job ID R-085741 Date posted 07/03/2020

Pharmaceutical Quality systems management
质量体系管理
-    Coordinate Quality key systems in place and improvement, including, but not limited, 组织和协调关键质量体系的运行和改善,包括,但不限于, 
•    GMP training GMP培训
•    Document management文件管理
•    QAA management质量保证协议的管理
•    CAPA address, feedback and follow up CAPA的制定,反馈和跟踪
•    Change control生产变更
•    Quality risk management风险管理
•    Self-inspection自检
-    KPI data collection and reporting to global KPI数据收集和报告给总部。
-    Quality performance review and reporting 质量绩效回顾和报告
-    Continuous improving on quality and compliance持续改进流程
QA daily affiars
QA日常事务
-    Coordinate and lead GMP inspection from external heath authorities
协调和组织官方机构对生产基地的GMP审计工作
-    Coordinate the communication with local healthy authority 
协调和当地药政部门的沟通
-    Coordinate Site registration in China market. 
协调中国市场的工厂注册的相关事宜
-    Support CMCRC for site registration and product registration in global markets.  
协助CMCRC在国外市场的工厂注册以及产品注册的相关事宜  
-    Support China RA for product registration in China market. 
协助法规事务部在中国市场的产品注册的相关事宜
-    Support China Tendering team for entrusted inspection in China market. 
支持商务招标团队在中国市场招标需求的委托检验事宜.
-    Provide support and administration on QA E-system, eg. SAP, AZDoc, OCM, IDM etc.
提供质量相关的电子系统的支持和管理,如SAP,AZDoc,OCM, IDM等
SHE 
安全环境健康    -    Compliance with AZ code of conduct and SHE requirement.
符合公司的行为规范和SHE的要求



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.