大学本科及以上学历，制药相关专业或工业工程或同等专业 College degree or above, major in pharmaceutical related subject or industrial engineering or equivalent 5年以上制药相关经验 5+ years’ related experience in pharmaceutical company 拥有变差变更质量事件处理的经验和能力 Have some initiating experience of change control or deviation. Participated in implementing of change control or deviation investigation and improvement 有监管和客户审计经验者优先 Experience of regulatory and customer audits is a plus 有CDMO项目经验优先 CDMO project experience is a plus 有效的沟通和良好的人际交往能力 Effective communication and good interpersonal skills 具有团队合作能力 Ability to collaborate and deliver through team work 能够在繁忙的环境中有效地执行多项任务 Ability to perform multiple tasks effectively in a busy environment 具备解决问题和调查问题的能力 Demonstrated skills for problem solving and investigation 熟悉FDA、EU、WHO、NMPA和PIC/S GMP要求者优先 Knowledge of FDA, EU, WHO, NMPA and PIC/S GMP requirements is a plus 了解ICH指南优先 Knowledge of ICH guidelines is a plus 有生物制药或大分子领域经验优先 Experience in biopharma or big molecule industry is a plus 熟悉疫苗/mAb的生产工艺优先 Knowledge of manufacturing process of vaccines or mAb is a plus 拥有实际的处理质量事件经验 Hands on experience of handling quality events 现场QA for 生产管理, 参与相关区域质量事件的处理和签批 Involve with Online QA for MFG Management, handle and review quality events in related area 负责区域和设备的检查及放行 Be responsible for inspection and release of status of area and equipment 协助数据分类、定义并执行数据审核策略 Contribute to data classification, define and execute data review strategy 负责按照法规、项目、公司流程规定对工艺和操作文件进行审核和批准 Be responsible for reviewing and approval of process and operation documents following requirements of regulations, projects and company’s procedures 定义并执行工艺及操作文件的管理策略 Define and execute strategy for management of process and operation related documents 负责所有物料状态的管理 Be responsible for management of all material status 参与现场活动的质量事件管理 Participate in quality events handling related to online activates 负责现场QA相关程序文件的维护和改进 Be responsible for maintenance and improvement of online QA related procedures l 放行QA管理 Release QA Management 负责对物料进行完全放行、授权使用放行或拒绝放行操作，并发放相应的放行标签。 Perform full release or authorized release or reject to materials and issue related labels. 负责原液和成品批放行。 Be responsible for batch release of DS and DP. 在客户和**法规审计准备中负责领导业务部门话题的准备和预演 Lead the preparation, rehearsal and defense of QA for business topics for ****** audit and regulatory inspection 培训工程和验证管理的QA SME Train and coach SMEs for Quality for Engineering and CQV 支持其他客户访问和审计质量相关的部分Support other external visits and inspections related to quality CDMO项目的质量管理Quality management of CDMO projects 协助项目的准备和执行Cooperate and contribute to preparation and execution of projects 在确保项目活动合规和高效，合作并作出贡献，并确保高成功率 Cooperate and contribute to ensure project activities in a compliant and efficient manner, and ensure high success rate 在解决问题，偏差调查，纠正预防措施和变更提供质量监督 Provide quality oversight in troubleshooting, deviation investigation, CAPA and change control 为卓越运营提供贡献Contribute to campaign operation excellence 客户以及**审计中准备、演练、以及回答现场QA相关话题 Lead the preparation, rehearsal and defense of online QA topics for ****** audit and regulatory inspection 培训和指导现场QA SME Train and coach SMEs for Online QA 支持其它涉及到质量话题的外部访问以及检查 Support other external visits and inspections related to quality topics l 现场QA for QC&AS管理, 参与相关区域质量时间的处理和签批 Involve with Online QA for QC&AS Management, handle and review quality events in related area l 定义并执行现场监控策略以确保执行的活动符合法规、项目、公司流程规定。 Define and execute strategy for routine area monitoring as appropriate to ensure the activities in compliance with requirements of regulations, projects and company’s procedures l 负责QC& AS区域和设备的检查及放行 Be responsible for inspection and release of area and equipment l 协助数据分类、定义并执行数据审核策略 Contribute to data classification, define and execute data review strategy l 负责按照法规、项目、公司流程规定对质量控制和操作文件进行审核和批准 Be responsible for reviewing and approval of quality control and operation documents following requirements of regulations, projects and company’s procedures l 定义并执行分析、质量检测及操作文件的管理策略 Define and execute management strategy of assay、quality testing and operation related documents l 从客户的角度，支持内部团队的决策 From the ******s’ point of view, support other internal teams to make decision; l 建立和维护良好的团队关系 Build and maintain excellent relationships with ******s; l 维护并参与质量体系的持续改进 Maintain and contribute into quality system continuous improvement; l 支持性工作 Supporting work: · 支持CMC项目团队的项目运营和问题解决 Support CMC project team to run projects and problems solving; · 支持质量事件相关的活动，如需要 Support quality event activities when necessary; · 支持审计准备工作，如需要 Support audit readiness preparation when necessary; · 支持法规审计，如需要 Support regulatory inspections when necessary; · 供应商管理，如需要 Supplier management l 理解和遵守EHS和ESG规则 Respect and follow EHS and ESG rules l 直接主管分配的其他任务 Other tasks assigned by line manager;