1. Able to complete daily work independently. 个人贡献者，能够独立熟练完成日常工作 2. Carry out daily production work strictly according to standard operating procedure. 严格按照标准操作流程执行日常生产工作 3. Familiar with the work flow and make timely and relevant records 熟悉工作流程，做好及时的相应记录 4. Assitant production management team to monitor production environment, process, hygiene, facilities to make sure all production activities comply with SOP requirements， 协助生产管理人员监督生产环境、工艺、卫生、设施等,确保所有生产活动符合SOP要求。 5. Prepar the validation protocols for production process, equipments, cleaning etc. 准备进行适当的工艺、设备、清洗等验证文件。 6. Imprementation and monitor the actions of Change Control, CAPA for deviations or complaints related to production. 生产中所有变更、偏差及生产相关的投诉问题纠正措施和预防措施的及时落实及监控 7. Develop necessary SOPs and ensure the implementation and improvement. 组织制定相关的岗位操作规程并确保执行及持继改进。 8. Be responsible for introducing, development and improvement of GMP，HSE and lean production. 负责在GMP、HSE、精益生产等体系方面的推广、维护和改进工作。 9. Other tasks temporarily assigned by department manager. 按时完成上级临时交办的或部门间合作的其他工作任务。 Quality Responsibility 质量职责 1. Report product complaints and adverse drug reactions according SOP requirements. 根据SOP要求报告产品投诉和药物不良反应。 2. Participate in and complete personal training on time. 按时参加并完成个人培训。 3. Operate in accordance with SOP standards。 按照SOP标准要求进行操作。 4. Fill in GMP documents and records in accordance with SOP standards. 按照SOP要求填写GMP文件和记录。 5. Report abnormal conditions in a timely manner. 及时汇报异常情况。

1 本科及以上学历，医药化学相关专业 2 英语可完全作为工作语言，能够流利和global会议沟通，接受全英语面试 3 三年以上GMP质量或生产工作经验，熟悉偏差变更等质量管理