无锡药明合联生物技术有限公司
制剂灌装 Shift Leader
岗位职责
负责下属员工能力构建和新员工能力培养;Be responsible for staff capacity building and on-boarding staff ability cultivating.2、确保生产过程中各环节符合国内外GMP要求,按照SOP及MBR要求完成灌装线岗位药品生产,能持续进行生产工艺流程的优化,提高生产效率,使产品质量得到有效保障;Ensure the production process in accordance with the domestic and international GMP
任职要求
, DP manufacturing operations strictly following SOP and MBR in filling line position, continuously optimize production process, improve production efficiency to ensure the quality of the product.3、负责生产相关记录的填写和监督审核工作;Be responsible for the filling, supervising and reviewing work of production-related records4、参与并管理属下员工生产设施设备的日常使用、清洁、维护,确保设备处于有效运行状态;Participate in and managing the daily use, cleaning and maintenance of production facilities and equipment, to ensure the equipment in effective operating condition.5、遵守公司EHS的相关政策和规定,保证生产安全进行及生产现场的清洁卫生;Complying with company's EHS policies and regulations, assuring safety in production and keep the workshop clean and hygienic stay still.6、维护良好的生产秩序,保证生产正常运行,贯彻相关的员工守则,对员工的表现进行考核等有效管理。Maintain good production order, ensure production running smoothly, implement the employee code, and conduct effective management of staff performance assessment.7、负责SOP等文件的起草和维护工作;Ability to draft and review deviation investigation, variation and SOP documents in the area8、参与所在区域偏差调查、制定及审核CC和CAPA;Ability to conduct deviation investigation, draft and review change control and corrective and preventive actions.9、 完成领导安排的其他临时工作。Complete other interim work assigned by leadership.大专及以上学历,生物学、药学等相关专业,有GMP生产、微生物相关知识。Junior college degree or above,major in biology, pharmacy or a relevant discipline. Related knowledge of GMP production and microorganism.至少2年生物制药行业的相关工作经验。Minimum 2 years work experience in biopharmaceutical industry较强的团队管理与团队合作能力Strong team management and team cooperation ability.能灵活调节时间,满足工作要求。Flexible with the working time as required.
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