工作职责

 Write/update the production processes and procedure according to the cGMP requirement and  requirement. 根据现行版GMP要求及流程建立或更新生产工艺及流程。 As the key player to complete all the validation activities according to cGMP requirement and  quality system. 根据GMP要求及质量体系完成相关验证。 Continuously optimize the operational and quality processes and equipment to achieve the company strategy target. 持续优化生产、质量流程及生产设备实现公司战略目标 Participate and present documents/process as the key player in production area if the audit or inspection, ensure to pass the inspections or audit, take the effective actions if any findings related to production area. 代表生产参加内外部质量审核，确保生产文件及工艺顺利通过内外部质量审核，并对审核过程中由任何发现项采取有效措施。 Handle the non-conformity and CR cases for the validation and daily operation. 处理验证及日常生产中的偏差及变更。 Train the future employees, e.g. operators, technicians and engineers 培训部门其他人员，如操作工、技术员及工程师。 Capable of operating the equipment and other operational procedure. 能正确操作生产设备及其他生产岗位。 Ensure overall product quality in production area; and ensure good cGMP understanding and Quality Mindset on production teams. 全面负责生产产品质量，确保生产团队对现行GMP要求和质量mindset有良好理解。 Use the LEAN tools to improve the current process and operation, ensure that the production provides cost-effective and high quality product timely and efficiently. 应用精益工具改善现有流程和操作，保证生产能及时有效地提供高质量产品及有效成本控制。 Assist to production manager to manage production team to make sure all activities during the production shift comply with SOP, GMP, EHS and other regulatory requirements. 协助生产经理管理生产团队，确保该班组员工的所有行为符合SOP,GMP,EHS及公司的各项管理制度和其它规范的要求。 Assist dept. manager to achieve the KPIs and VIP project.协助部门经理完成各KPI及VIP项目。

Requirements 职位要求

At least a bachelor in Pharmacy or Engineering. 药学或工科背景, 学士学位以上。 More than 3 year of production experience in a manufacturing environment preferably in the pharmaceutical, medical or similar industry. 制造行业 3 年以上生产工作经验；医药, 制药及相关行业优先。 Familiar with the processes of pharmaceutical manufacturing and GMP management. 熟悉药品生产流程及 GMP 管理规范。 Good oral and written English level. 良好的英语水平。 High level of attention to detail. 关注细节。 Independent and honest. 能够独立工作，诚实。 Have good leadership and communication skills. 具备领导能力并很好的沟通能力。 Demonstrate a strong trouble shooting ability and a desire to learn new things. 具备很强的问题解决能力，并有学习新事物的愿望。 Excellent manufacturing skill, to use the LEAN tools to