Sr. Engineer, Compliance
AstraZenecaChina - wuxiUpdate time: August 12,2021
Job Description
Responsibilities
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
Requirements:
- University graduate, major in pharmaceutical or related subjectsb本科或以上，药学或相关学科
- 10+ years experience as quality assurance 10年QA工作经验
- 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, SAP or similar system熟悉微软应用，SAP或类似系统
- Good English 英语水平出色
- 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
11-8月-2021Closing Date
30-9月-2021AstraZeneca 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.
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