1. Perform assessment about cleaning verificaiton/validation subject to equipment grouping, sampling method, sampling location, residue standard and so on; 执行清洁确认/验证相关的评估,包括设备分组,采样方法,采样位置,残留标准等待; 2. Draft cleaning validation/verification protocol and report; 起草及审核清洁验证/确认方案和验证报告; 2.Ornanize manufacturing department to perform cleaning verification/validation; 组织生产部门执行清洁确认/验证; 4. Deal with cleaning verification/validation deviations and changes; 清洁验证偏差和变更的处理; EHS 安全 Conscientiously implement the relevant safety laws, regulations and standards, and actively communicate and implement the company's safety instructions. 认真执行相关安全法律法规及标准,积极传达、贯彻公司各项安全指令。 Others: 其他: Support for other relevant GMP activities; 其他相关GMP活动的支持; Complete other tasks assigned by superior leaders; 完成上级领导交办的其他工作; Optimize the work arrangement continuously for high efficiency. 优化工作安排,持续保持工作的高效。 Job Requirements 任职要求 Bachelor Degree or above 学士及以上学位 Pharmacy, Chemistry, Biochemistry and equivalent is prefer 药学、化学、生物化学及相关学科优先 More than 3 years working experience in GMP, more than 2 years working experience in TCU equipment verification. 3年以上GMP工作经验,2年以上工艺设备验证相关工作经验。 Good English reading and writing skills. 良好的英语读写能力。 Good understanding of regulatory requirement (NMPA, USFDA and EMA etc.) . 对NMPA、USFDA和EMA等法律法规有良好的理解。 Organize and coordinate the implementation of validation. 组织和协调验证工作的实施。 Good communication skills. 具有良好的沟通技巧。