职位详情

Job Description 职位目标AIM OF POSITION: 协助主管培训，领导整个团队，协调部门内各个团队的工作。根据cGMP，SOP以及其他由公司颁布的法规对操作工进行指导。创建和更新相关的SOP。根据cGMP以及通用电气药业SOP，协助主管高效率的完成日常的工作并且确保所有的产品都具有高质量。 To assistant the Supervisor in training, lead the team, coordinate with other team in packaging operation. Give the instruction to the operators regarding cGMP, SOPs and other regulations which is issued by the company. Create and update SOPs for the related operations. Assist the supervisor to carry out daily operation in high efficiency according to cGMP and GEHC. SOPs to ensure all productions are in repeatable high quality. 职责RESPONSIBILITIES: 人员Personnel 根据生产要求领导和合理分配操作工以及劳动资源。 完成对操作工的日常培训。 负责对操作工进行评估。 当主管缺席的情况下行使主管的职责。 Lead the operators and rationally allocate labour forces according to the production requirements. Carry out regular training program for operators. Be responsible for evaluation of operators. Take the responsibility of the Supervisor in his/her own field when the Supervisor is absent. 2. 生产管理Operation management 根据cGMP和通用电气药业SOP检查每一步生产程序； 检查并填写批文件和记录本； 根据相应的规格检查接收的物料； 检查设备/机器处于良好的状态； 根据cGMP和通用电气药业SOP检查工作环境； 创建和更新相关的SOP，在生产前和生产后完成对岗位的检查； 负责下一步生产和下一班次的交接； 负责KPI的记录； 负责造影剂、凯思立以及灯检线； 担当SAP系统中的最终用户，并维护相关的信息； To check each appreciate operation procedure is according to cGMP and GEHC SOPs; To check and fill batch document and logbooks; To check the incoming material according to the specifications; To check equipment/machine in a good status; To check environment according to cGMP and GEHC SOPs; To create and update relative SOPs. Carry out site inspection before and after production; Be responsible for handling over the product to the next process and next shift. Be responsible for KPI record. Be responsible for Contrast Media、Calcichew and Visual Inspection line. Act as end-user in SAP system and maintain the relevant information in the system. 3. 质量管理Quality management 负责保持高质量的生产。 不断地改进生产质量。 检查中间控制（IPC）的记录 汇报生产过程中的偏差并指导操作工解决质量问题。 及时发现并填写生产、环境、健康、安全方面的偏差。 参与并协调安装确认、运行确认、性能确认或者是再验证，以及其他的验证作。 Be responsible for the continuous high quality production. To continuously aim at the improvement of production quality. Check the record of IPC (In Process Control). Report the deviation in process and instruct operators in solving quality problems. Finding and fill in the deviation of production and environment, health, safety (EHS) in time. Take part in and coordinate in IQ, OQ, PQ or revalidation and other validation work. 资格/经验QUALIFICATION/EXPERIENCE: 大专或相当于大专毕业，至少2年制药或相关行业工作经验。 良好的英文和电脑能力。 College education or equivalent is required, and at least 2 years experience in the pharmaceutical or related industry. Good English and computer skill is required.