Sr.QA Engineer

Description

工作描述简述 Execute the responsibilities of China MCOQ and implementing the GMP/GDP Quality System Framework in local markets. 落实中国MCOQ在本地商业市场的职责和GMP/GDP质量体系框架的实施。 Support excellence in MCOQ GMP&GDP Quality activities to maintain the local License to Operate*. 支持MCOQ GMP&GDP 质量活动的卓越提升，支持维护本地的经营许可证*。 Assess and deploy execution of the GMP/GDP/GSP related policies & regulations in China, as well as global standards & QCMs. 评估并实施中国GMP/GDP/GSP 相关政策法规、全球标准以及QCM。 Maintain / improve GMP/GDP/GSP compliance in daily product supply. 维护/改进产品供应日常运作中的GMP/GDP/GSP符合性。 Responsible for the intake & customer response of product quality complaints (PQC) and product security complaints from China market. Responsible for the handling of PQC related compensation request from Chinese customers. 负责中国市场产品质量投诉、产品安全投诉的接收与客户回复；负责处理来自中国客户的产品质量投诉相关赔偿诉求。 Deliver China GSP regulation and promote Quality Culture to business partners. 向业务合作伙伴阐述中国GSP法规要求并推广质量文化。

Job Responsibilities 工作职责

Daily affairs management 日常事务管理

Maintain the QMS of China MCOQ to ensure the compliance to AstraZeneca QCM &standards and GSP regulations regarding to China trading companies. 对于负责领域的质量管理模块，确保相关流程及操作符合阿斯利康QCM标准和中国GSP等相关法规的要求。 Serve as quality liaison to the drug regulatory agency (if required), support GMP&GDP audits and inspections, and support the smooth closure of inspections. 作为药监机构的质量联络人（如需要），支持 GMP&GDP 审计和检查，并支持检查顺利关闭。 Ensures effective and timely product quality and security complaint management by China markets. 确保中国市场的产品质量投诉及产品安全投诉有效和及时的管理。 Create the links between China MCOQ and business stakeholders like commercial teams, CDC, supply chain, IT, ITQM, Business Units, Marketing, legal, PR, China Patient Safety, Operation Sites etc. in terms of quality management and optimization. 建立中国MCOQ和业务利益相关方如商务团队、储运团队、供应链、IT、IT质量管理, 销售部门、市场部门、法务、公共传播部、中国患者安全部、供应基地等的联络沟通，以支持质量管理和改善。

Continuous Quality Improvement 持续质量改善

Identify the quality and compliance gap and work out improvement plan with area manager.识别质量合规风险，协同相关部门制定改进计划。 Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally. 为专业领域的开发流程做出贡献，并为区域或全球的标准的制定提供技术意见。 Leads trouble shooting activities to resolve existing problems, make complicated judgements.支持故障排除活动，能够解决复杂的问题。 Drive the quality process improvement and simplification as quality business process champion, ensuring GMP/GDP/GSP compliance and AZ global standard compliance. 作为质量业务流程负责人驱动质量流程的改进和简化，确保GMP/GDP/GSP法规符合性及阿斯利康全球标准符合性。

SHE 安全环境健康

Identify and understand the SHE risk factors within the department. 识别和了解本部门的安全危险因素。

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

Bachelor’s degree or above, majored in a science/technical field such as Pharmacy, Biology, Chemistry, licensed pharmacist is preferred. 大学本科以上学历，药学或相关专业, 执业药师为佳。 5+ years prior experience in GMP/GSP/GDP and compliance management environment.制药行业GMP/GSP/GDP 5年以上工作经历。 3+ years’ experience of supplier quality management and distribution quality management. 3年以上供应商质量管理和药品经营质量管理经验。 Experience of working cross functionally across the supply chain with groups such as regulatory affairs, manufacturing, supply and account management, etc. 跨部门合作工作经历，如法规注册、生产、供应链以及客户经理等。 Solid GMP/GSP/GDP and quality system management knowledge, and pharmaceutical knowledge. 扎实的GMP/GSP/GDP和质量体系管理和药学知识。 Good problem solving ability, especially leading to solve the quality-related problems.良好的问题解决能力，尤其能领导经营过程中的质量问题的解决。 Good English. 英语水平良好。 Good Computer skill. 电脑使用熟练。 Good communication skills, proactive leadership, strong quality, and 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

17-6月-2024

Closing Date

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