职位描述
职位概述：
– 原液操作员需要按照现行GMP标准及生产标准操作规程的要求下，完成制剂原液的生产操作任务。
The DS operator is responsible for the execution of tasks needed to produce biopharmaceuticals under current "Good Manufacturing Practices" (cGMP) and in accordance with Standard Operating Procedures.
工作内容：
– 在SOP的指导下，进行原液的生产操作。包括但不限于以下生产活动：培养基/缓冲液制备，细胞接种操作，生物反应器操作，过滤设备操作，层析系统和超滤洗滤系统操作等。
Perform DS manufacturing under standard operation procedure, include but are not limited the following activity: Media/Buffer preparation, cell inoculum, bioreactor, filtration equipment, chromatography skids and UF/DF skid.
– 在SOP的指导下，能够对以上相关生产设备进行清洗及简单的维护工作。
Perform the cleaning and maintenance procedure of related equipment under SOPs.
– 在生产主管的指导下，能够协助编写标准生产规程。
Edits/write SOPs as directed by the production supervisor.
– 按照SOP要求进行相应的取样操作及数据记录。
Sampling and data recording based on SOPs.
– 按时完成被分配的培训项目并通过考核
Ensure to complete the training curricula on time and pass the learning assessment.
– 为保证新产品、新设备与新工艺顺利实施，在他人指导下参与新产品试制和新设备的调试
Participate the new product technical transfer and new equipment IQ/OQ as directed by experienced stuff.
– 根据生产需要进行倒班生产。
– Attend shift work according to manufacturing requirement.
任职要求：
教育程度/经验 Education/Experiences
– 高中以上学历，药剂/药学相关专业。
At minimum high school diploma is required, Biotech/pharmacy/Chemistry or equivalent major.
– 有相关工作经验者优先。
Experience working in related environment is a plus.
特别知识/技能 Specific Knowledge & Skills
– 良好的口语和写作沟通能力、有一定的英语和计算机基础知识、具有团队合作精神
Good oral and written communication skills are required. Skill of English and computer, a good team player
– 了解GMP相关知识者优先。
Familiar with cGMP is a plus.
