To establish and sustain a culture of compliance at Wuxi Supply Point that is proactive and professional to meet
regulations, adds value and delivers a competitive advantage to the business.
建立和保持质量合规体系，以符合法规要求、增加价值并为公司业务提供竞争性的优势。
To provide coordination and oversight of functional quality & compliance and encourage function ownership of
Quality.
通过对各部门质量及合规性提供适当的协调和监督，提高和倡导各部门质量的主人翁意识。

Key Tasks
主要任务
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 变更控制
• Quality risk management 风险管理
• Self-inspection 自检
• Complaint management 投诉管理
- 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 GMP inspection from external heath authorities
协调官方机构对生产基地的GMP 审计工作
- Coordinate Site registration in China market.
协调中国市场的工厂注册的相关事宜
- Support CMCRA for site registration and product registration in global markets.
协助CMCRA 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.
- Be responsible for Site Master File Management
负责工厂主文件的管理
- Be responsible for site certificate management
负责药品生产相关证书管理，包括生产许可证、产品注册证等

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

Education, Qualifications, Experience
教育、资质、经验
Essentials 必 需
• University graduate, major in pharmaceutical or
related subjects
大学毕业，药学或相关学科
Desirable 理 想
• 5 years plus working experience in QA function
of Pharmaceutical company
制药公司5年以上的QA部门工作经验

Capabilities
能力
• Good GMP and quality system management
knowledge 良好的GMP 和质量体系管理知识
• Knowledge of product process and typical
equipment 熟悉产品生产和设备
• Working knowledge of Microsoft applications
熟悉微软应用
• Good English 英语水平良好
• Good Computer skill 电脑使用熟练
• Good communication skills, proactive
leadership, strong quality minds and strong
service minds 良好的沟通技巧，主动的领导意识，强烈的质量观念和服务意识

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.