Roles/Responsibilities
职责:
Lead and participate in the activities including URS/FAT/SAT/IQ/OQ/PQ of DS department automated equipment
组织并参与原液生产自动化设备的URS、FAT、SAT、IQ、OQ、PQ。
Lead and participate in preparing, revising, and management of automation recipes for the DS department.
组织并参与原液生产自动化配方的起草,修订,管理等
Lead and participate in computer/software validation jobs of DS department
组织并参与原液生产电脑/软件的验证工作
Lead and participate MES project, and response for DS recipe development and maintenance of recipes.
组织并参与工厂MES项目,并负责DS MES处方管理及维护。
Provide automation/MES related trouble shooting support when any issue occur during DS routine manufacturing。 To ensure DS production meet production plan.
为原液生产出现的自动化和MES相关的问题提供问题解决支持。保证生产按计划进行。
Provide support on quality audit as SME of DS automation/MES
作为原液生产部门自动化和MES SME支持工厂质量相关审计
Lead and participate related change control, deviation and other actions as automation/MES SME
作为自动化和MES的SME,组织并参与自动化和MES相关的变更控制,偏差及其他行动项的执行。
Responsible for preparation/revision to SOP