Brief Job Description 工作描述简述

·       To establish and sustain a culture of regulatory compliance at Wuxi Supply Point that is proactive and professional that meets regulatory requirements, adds value and delivers a competitive advantage to the business.

   建立和保持法规规范体系，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。

·       Contribute to the QA function in developing / improving quality management system

   协助质量部改进质量管理体系

·       To provide coordination and oversight of functional quality & compliance and improve 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，提高各部门质量的主人翁意识。

Typical Accountabilities

主要职责

Quality systems management质量体系管理

-        Provide coordination and oversight of functional quality & compliance

对部门质量及合规性提供适当的协调和监督

-         Lead and coordinate Quality key systems in place , including, but not limited, 组织和协调关键质量体系的运行，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

•         Change control变更控制

•         Quality risk management 质量风险管理

•         Self-inspection自检

•         Complaint Management 投诉管理

•         Management review 质量管理回顾

-        Continues improvement the quality system management with Lean tools

利用精益工具持续改善质量体系管理

-        Lead and support QAF/ site quality continuous improvement project

主导/支持质量部/工厂持续改善项目

-        Maintain the good quality culture in site

维护工厂良好的质量文化

Quality Compliance Routine质量法规规范日常事务

-        Provide support on quality oversight on Non-PET business at Wuxi site, e.g. QC. E&SHE department, including change control, complex quality issue handling, validation etc.

对非PET部门的业务，如QC，工程部等提供QA支持，包括变更管理，复杂的质量事件处理，验证活动等

-        Lead intelligence of external regulation, provide compliance advise when necessary

组织外部法规的解读评估, 并在需要的时候提供合规评估意见

-        Support different quality teams in QA function as SME when necessary

必要时作为SME支持工厂各质量团队的业务

-        Support investigation on QA/QC related issue

支持QA/QC相关事件调查

-        Support 3PS & CMO affairs

支持3PS和CMO事务

-        Coordinate and lead GMP inspection from internal/external

协调和组织内外部对生产基地的GMP审计工作

-        Lead localization of global QCM to ensure comply with corporate quality system

组织全球QCM的本地化，确保本地流程设计符合全球质量体系要求

-        Maintain and improve PQS procedure and electronic system

维护优化PQS流程和相应的电子化系统

-        Provide quality system related training, Coach and develop quality professional capability for QA function employees

提供质量系统相关的培训，指导和发展质量部员工质量专业能力

-        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 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

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 and Capabilities 教育、资质、经验和能力

University graduate, major in pharmaceutical or related subjects

大学毕业，药学或相关学科

8 years of Quality working experience

8年以上质量工作经验

Have work experience for a foreign pharmaceutical company

制药外企工作经验

Cross Function working experience

跨部门工作经验

Solid GMP and quality system management knowledge

良好的GMP和质量体系管理知识

Expert of quality management system and key process

质量管理体系关键流程专家

Knowledge of up-to-date technology and regulatory trend

对行业技术和法规具有与时俱进的认识

Expert of quality risk management

质量风险管理专家

Knowledge of process control methodology and statistics, for example Ppk, FMEA

具备过程控制方法和统计学的知识，类似Ppk, FEMA等工具

Working knowledge of Microsoft applications, SAP or similar system

熟悉微软应用，SAP或类似系统

Good English英语水平良好

Good Computer skill电脑使用熟练

Good communication skills

良好的沟通技巧

Strong quality minds and service minds

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.