Job title职位名称: China EM&S QA Manager Location工作地点： Shanghai 上海 About the job工作职责 We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where
Job Description EXTERNAL QUALITY ASSURANCE -Senior Specialist Qualified Person (QP) China The Position The Product Quality Manager (PQM) Senior Specialist is responsible for ensuring that all Company products managed by External Quality Assurance (EQA) are manufactured,
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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
岗位职责： 负责公司GMP培训体系搭建、落地执行与持续优化，维护并各部门岗位培训矩阵、课程体系及考核标准，适配法规更新、文件变更、岗位变动等场景。 统筹全员GMP培训管理工作，包括新员工入职GMP培训、在岗人员年度复训、法规专项培训等，保障全员上岗资质合规。 常态化开展跨部门培训需求调研，结合年度质量目标、岗位风险、审计整改要求，制定年度、季度培训计划并落地跟进、闭环落地。 负责Veeva培训管理系统日常运行，完成培训台账、培训记录、考核结果的追踪，确保培训数据真实、完整、可追溯。 负责培训模块内部自检、外部审计、客户审计迎检工作，识别培训风险，落实整改与持续改进。 建立培训效果评估机制，通过理论考核、现场核查等方式评估培训有效性，持续优化培训形式与课程内容。 按需求输出月度/季度/年度培训工作总结。 完成上级交办的其他相关工作。 任职要求： 本科及以上学历，药学、制药工程、生物技术、化工、质量相关专业 。 5年及以上制药行业GMP工作经验，2年及以上专职GMP培训体系管理经验，有完整培训体系搭建经验优先。 熟悉中国GMP及行业指导原则，熟悉药品生产、质量系统培训合规要求，熟悉培训全生命周期管理流程 。 熟练操作Office办公软件、LMS培训系统，能够独立制作培训课件、统计分析培训数据、输出报告 。 熟悉药企文件管理规范，可独立完成培训流程、记录、方案的编写与修订 。 具备良好的跨部门沟通协调能力、执行力与风险意识具备基础英语读写能力 。...
Typical Accountabilities Specific Responsibilities/Tasks Establishment and maintenance of Quality Management System (A Certificate) of ADC products ● Being responsible for establishing and maintaining the Quality Management System of ADC products that comply with the requirements of
Job Description Your Responsibilities • Act as the primary person responsible for safety and environmental protection for this position and the work under its charge. Study and abide by safety and environmental protection-related laws, regulations, company
Job Information职位信息 Job title职位名称: QA Specialist QA专员 Location工作地点： Beijing, China 中国北京 % Remote working and % of travel expected 远程办公和出差的概率：N/A Job type工作类型: Full time全职 Site/Unit 区域/事业部：Beijing Site/ M&S China北京工厂/中国制造与供应事业部 About the job工作职责 Our Team我们的团队： The M&S division encompasses
岗位职责： 参加GMP培训并遵循GMP规则在车间内完成生产任务； 负责和保证下游生产各工序按照公司要求开展生产工作； 负责组织生产下游部门GMP相关文件的撰写、升版和审核工作； 负责改进并优化生产流程及工作方法，定期进行总结和汇报； 负责板块内生产人员的技术、设备、规范、工艺等相关文件的培训与考核； 负责组织和协调变更的发起和组织风险评估以及方案制定等工作； 负责下游生产中出现的偏差、偏离、异常事件的调查和组织工作（偏差、变更、CAPA等）； 参与NMPA、FDA等审计部门或合作单位审计，并根据审计整改项执行整改及反馈； 与研发部门、MSAT部门、供应链部门、工程部门、QA部门、QC部门等相互合作，推进生产的顺利进行。 任职要求： 本科及以上学历，生物制药、生物工程、生物技术等相关专业； 工作经验：本科≥10年、硕士≥8年、博士应届； 本科以上学历，具备10年以上（硕士8年）蛋白类药物下游工艺放大经验或商业化GMP生产相关工作经验以及人员管理经验； 掌握下游生产设备的操作原理、维护、管理； 熟悉生物药GMP厂房的运行和管理； 具备蛋白纯化板块人员招聘、培训、带队伍、现场管理等职能； 具备控制所管理板块预算和成本，实现投入和产出合理化。； 具有良好的沟通表达能力； 熟悉生物制药领域GMP的相关法规要求； 熟悉偏差发起、调查、关闭和CAPA执行的整个质量管控过程； 具备较好的英文阅读和书写能力，能够审阅GMP相关文件； 具有吃苦耐劳的品质和良好的身体素质，与积极向上持续学习的能力； 具备国内/国外相关审计经验； 英文CET-6以上。...
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
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About the job Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on
中国，上海; 南通，中国 | 全职 | Job ID: 10361 About the role: About the Role: The IT system validation manager is responsible for the validation of the IT systems (largely SAP S4HANA), which shall operate in compliance
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
About Us: Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Job title职位名称: Batch Release lead 批次放行负责人 Location工作地点： Beijing北京 About the job工作职责 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply
About Vita Green Group Vita Green stands at the forefront of the health supplements industry, committed to enhancing well-being through innovative research and cutting-edge solutions. Our GMP and HACCP-certified facilities ensure top-tier quality control at every step—from