锦鲤求职岗位描述
本科以上学历/ 2~5年工作经验
Senior college or Bachelor degree or above / 2~5 years of work experience
对于生物制药制剂工艺流程有一定的了解优先，如无菌灌装。
Have adequate knowledge about the biological pharmaceutical DP process would be an advantage, such as aspect filling.
良好的英语读写能力；
Good English reading and writing skills
熟悉相关的法规、标准、指南等，熟悉制药制剂工艺及相关设备知识
Advanced knowledge about relevant regulations, standards, guidelines, etc. Familiar with pharmaceutical DP processes and related equipment information.
对偏差调查、变更流程及评估有较丰富的经验。
Extensive experience in deviation investigation, change control process and evaluation
GMP活动：参与新建和技术改造项目，负责或参与和DP设备/系统相关的调试和性能确认等工作。
GMP activity: Participate in new construction and technical transformation projects, and be responsible for or participate in debugging and performance qualification related to DP equipment/system
GMP活动：根据验证主计划起草相应设备/系统年度再验证方案和报告，确保所起草的文件满足现行GMP等相关法规及工厂验证规程的相关要求，包括但不限于以下设备/系统：
HVAC、PW、WFI、PS、工艺气体
制剂设备验证如清洗机、冻干机、灯检机、无菌灌装线、轧盖机、包装线等
GMP activity: Drafting the annual requalification protocol and report as per validation master plan, ensure the drafted document confirms to the relevant regulation and facility validation plan requirement, execute validation. Including but not limited to equipment/system below：
HVAC, PW , WF I, PS , process air system
DP process equipment such as washer, freeze dryer, AVI, aseptic filling line, capping machine, packaging line, etc.
GMP活动：根据偏差/变更等起草研究/测试方案摸索新配方（参数）并起草验证方案/报告对新配方（参数）进行性能确认，包括但不限于灌装线新增规格、灯检机新增项目、清洗机新增装载等。
GMP activity: drafting study/test protocol for recipe (parameter) development as per change control or deviation, and drafting validation protocol and report to qualify new recipe（parameters）, including but not limited to new specification introduced to filling line, new project introduced for AVI, new load pattern introduced to washer, etc.
GMP活动：做为SME主要参与审计，审计前负责准备MiniPPT, 参与MiniPPT 的跨团队讲演；作为SME回答审计官的提问，在收到审计发现项后参与完成审计回复和整改。
GMP activity: Participate in audit as SME, responsible for the preparation of MiniPPT, participate in the miniPPT cross function rehearsal before audit; act as SME answering the auditor’s questions, and participate in completing the audit reply and rectification after receiving the audit findings
持续改进：参与DP设备，技术技能等方面的持续改进工作如WBS项目，金点子，参与SME攻关任务，以优化流程，减少浪费，减少缺陷，提高效率；
Continuous Improvement: Participate in continuous improvement work in terms of DP equipment, technical skills, such as WBS projects, golden ideas, and participate in SME research tasks to optimize processes, to improve efficiency, reduce waste and defects;
项目管理/PPQ FL：作为项目FL参与项目验证工作管理，协调团队工作，管理项目Timeline，确保验证及时完成；
Project management/PPQ FL: Participate in project validation activities management as a FL, coordinate team work, manage the project timeline, and ensure that validation can be completed timely;
积极完成上级领导临时安排的工作。
Actively complete temporary work arranged by supervisor