Working for the manufacturing department, will be responsible for the following but not limited to:在生产部门负责但不限于下列工作:1.Responsible for the operation of equipment during manufacturing activities, Lyophilizer loading/unloading, filling an d capping machine an d documentation负责在生产活动期间的设备操作,冻干机进料/出料,灌装机和轧盖机以及文件记录。 2.Responsible for the personnel activities working in this area.负责在此区域内工作人员的活动。3.Provide technical mentorship to Manufacturing staff.为生产员工提供技术指导。4.Preparation, Review an d implementation of SOPs an d protocols for the process 起草、审核、实施工艺的标准操作规程和方案。5.Participate in all the operations including parts change over when required需要时,参与所有的运营活动,包括部件更换。6.Responsible for planning areas activities to keep high production productivity 负责计划区域内活动以保持高生产率。7.Support engineering department with relevant data for improving equipment efficiency an d productivity.为工程部提供用于提高设备效率和生产率的相关数据。8.Assist management during investigation reports.在调查报告期间协助管理工作。9.When required participate in the Operations Organization Meeting. 需要时,参与运营组织会议。10.Responsible to ensure the cleaning, sanitization an d Or decontamination of the cleanroom areas an d equipment are performed an d properly documented负责确保已执行洁净区和设备的清洁、消毒或去污工作,并已进行恰当记录。11.Responsible for ensuring the setup of the equipment / format parts are performed in accordance with the batch records.负责确保按照批记录,对设备/模具进行设置。12.Undertake aseptic simulations during the manufacturing activities process according to procedures.按照规程在生产活动流程中进行无菌模拟。32