岗位描述
岗位职责:
负责按GMP要求进行一次性系统、不锈钢系统的操作与清洁,进行培养基、缓冲液的配制。
Be responsible for the operation and cleaning of disposable system and stainless steel system according to GMP requirements, and preparation of culture medium and buffer solution
负责按GMP要求进行洁净区内的清洁消毒工作,如清场清洁和设备表面清洁等。
Be responsible for cleaning and disinfection in the clean area according to GMP requirements, such as site clearance cleaning and equipment surface cleaning
负责生产用物料车间内领用、复核、管理工作。
Be responsible for receiving, reviewing and managing the materials for production workshop
负责SOP/MBR等文件的起草/升版。
Responsible for drafting/upgrading SOP/MBR etc.
参与相关变更,偏差的调查执行,以及审计整改活动的执行。
Participate in the investigation and implementation of relevant changes and deviations as well as audit and rectification activities
负责配合部门对其他有需求的员工进行相关培训,并按时完成个人的培训任务。
Be responsible for cooperating with the department to provide relevant training for other employees in need, and complete personal training tasks on time
负责配合部门内其他GMP工作的开展,例如logbook复核、BPR的审核等。
Be responsible for cooperating with other GMP work within the department, such as logbook review, BPR review, etc.
负责电子批记录系统维护。
Be responsible for the maintenance of the electronic batch record system.
任职要求:
本科及以上学历,计算机专业或有计算机基础,或具有同等工作经验的人员,有2年及以上工作经验者优先。
Bachelor degree or above, major in computer science or with a foundation in computer science, or other related disciplines, or personnel with equivalent work experience,2 years or more experience preferred
具有较好的沟通能力和理解能力。
Good communication and comprehension
工作积极向上并具有良好的学习能力。
Positive work and good learning ability
熟练使用Word、PPT、Excel、Visio等办公软件。
Be familiar with office software such as Word, PPT, Excel and Visio
具有培养基/缓冲液配制等GMP生产操作的相关知识或经验。
Knowledge or experience in GMP manufacturing operations such as media/buffer preparation
具有吃苦耐劳的品质及良好的身体素质(至少提起15Kg的重物)。
Having hard-working quality and good physical fitness (lifting at least 15Kg heavy objects)