锦鲤求职岗位描述
Key Responsibilities主要职责
1. 设备生命周期管理，包括URS撰写，DQ, FAT方案审核, 新设备入厂计量，SAT方案审核，IOQ方案撰写和IOQ实施以及设备再验证，以及设备转移等；
Equipment lifecycle management, including URS writing, DQ, FAT protocol review, calibration assessment of new equipment, SAT protocol review, IOQ protocol writing and IOQ implementation as well as equipment revalidation, and equipment transfer;
2.设备相关的偏差撰写，调查以及CAPA项制定；
Deviations related to equipment writing, investigation and CAPA item formulation；
3.设备相关的变更撰写，以及行动项的跟踪完成；
Writing of equipment related changes and tracking completion of action items;
4.官方审计的组织，准备，以及现场应审，审计后复盘；
Organization, preparation and on-site review of official audit, and review after audit;
5.数字化的管理推动，例如电子开发的开发和维护，PI系统的应用开发；
Digital management push, such as development and maintenance of electronic development, application development of PI system；
6.不锈钢系统工艺的改进，例如不锈钢系统的Delta-v系统的程序搭建，修改；
Improvements to the stainless steel system process, e.g. program builds for the Delta-v system of the stainless steel system, modifications；
7. 结合产品工艺，操作工艺，优化改进当前设备工艺（硬件，软件，参数等）
Optimize and improve current equipment process (hardware, software, parameters, etc.) in combination with product process and operation process
Requirements岗位要求
1. 本科及以上，机械/自动化/化学/生物等相关专业
Bachelor degree or above on mechanical, automation chemistry ,biological and etc.,
2. 学习能力强，可快速适配新岗位，并能够在岗位压力下工作
Fast learner with quick adaptability to new roles and effective under pressure
3.熟练药厂GMP要求及国家的相关法律知识。
Be familiar with GMP requirements for pharmaceutical companies and relevant national legal knowledge.
4. 2年及以上制药/化工/食品相关行业设备，工艺相关工作经验；
Over 2 years of equipment or process related work experience in pharmaceutical/chemical/food-related industries;
5. 熟悉设备引进相关的FAT,SAT, IOQ，PQ等相关流程，熟悉变更以及对应流程；
Familiar with equipment introduction related FAT, SAT, IOQ, PQ and other related processes and familiar with changes and processes
6. 具备调查不合格以及异常事件，并撰写偏差报告，采取纠正和预防措施的能力；
Ability to investigate non-conformance and abnormal events, write deviation reports, and take corrective and preventive actions
7. 良好的英语听说读写能力；
Good English skills of both oral and writing
8. 具备一定的计量，机械，或者流体力学知识以及熟悉相关工作的设备原理；
Knowledge of metrology, machinery, or hydrodynamics and be familiar with the principles of relevant work equipment