Main responsibilities职责描述： Please indicate here the main job responsibilities请列举该职位的主要工作职责。 He take the charge of distribution, filtration, zonal centrifugation, and daily production organized, cleaning and disinfection, materials prepared, environment etc. He ensure that quality rules and HSE rules are followed up during manufacturing operation of purification area, and performs production process in a safe and efficient manner. 负责完成相关接收、过滤、区带离心，以及日常组织生产、清洁消毒、物料准备和环境监控等,在纯化区域的生产运作中遵守质量守则及健康环境安全守则，确保生产安全有效地进行。 关键职责Key Accountabilities： 1、个人发展Personal development • Focus on health, safety and environmental requirement of production, and make corresponding improvement and adjustment when necessary. • 关注健康、安全及生产环境要求并在必要时作出相应改善及调整。 • Continuously improve the capability in production ability, deviation handled, environmental control, qualification and validation, HSE and so on. • 持续提高个人在生产能力、偏差处理、变更控制、环境监控、确认与验证、HSE等方面的能力。 • Develop personal cross function and muti-skill Talent training. • 发展个人交叉岗位及多技能人才培养。 2、工作交付Work Delivery • Attend production operations of purification area and delivery production with quality and quantity. • 参与纯化区域的生产运作并按时按质按量交付产品。 • Ensure personal training and qualification on request; ensure materials supply and human arrangement. • 根据要求确保个人的培训及资质；确保物料供应及人力调配。 • Ensure production activity according related process procedure, SOPs and BPR, fill and delivery record and BPR in time. • 确保生产活动根据相关工艺规程，标准操作规程及批记录进行，按时填写和提交区域记录和批记录。 • Support/ input related production data in time. Resolve problem happened during production. Responsible for writing related technician document. • 按时提供/录入相关生产数据；解决生产中出现的问题；负责相关技术文件的编写。 3、质量系统实施Quality system implementation • Handle, investigate deviation from production area. Provide assessment for change control, CAPA and ER finished in time. • 处理、调查生产领域中发生的偏差；根据实际情况提出变更控制，及时完成CAPA、ER。 • Assisted by related department and CI group, complete machine/equipment/calibration/qualification/validation activity. • 在相关部门和持续改进组的协助下，按时完成规定的机器/设备/厂房的校准/确认/验证活动。 • Attend actively building’s GMP inspection, improve GMP compliance. • 积极参与车间GMP自查，促进部门GMP合规性。 • Undertake Bulk production area supervisor’s related authorization responsibility, check and sign related GMP document. • 承担原液生产部区域主管的相关授权职责，进行GMP相关文件审核和签名。 • Deliver appointed continuous improvement item and other job objective. • 交付指定的持续改进项目或其他工作目标。 4、实现目标、实施 公司价值观和文化Achieve the goal, implement company value and culture • Break down department objective and assign to individual objective, delivery employee performance regularly, guide employee in time to implement company development direction. • 分解部门目标并分派给各个体目标，定期提交员工绩效。 • Improve personal work positivity, strengthen department inner communication and cohesion, ensure to achieve work goal and high work efficiency. • 提高个人工作积极性，加强部门内部沟通和凝聚力，以保证达到工作目标和最高工作效率。 • Obey the work arrangement of the department or the direct superior, and actively participate in the backup and transfer of different positions. • 服从部门或直接上级工作安排，积极参与不同岗位的备份和转岗工作。

• Experience: More than 3 years of relevant work experience 工作经验: 3年以上相关工作经验 • Soft skill: Able to operate office software such as Word, Excel, etc. Able to write documents, processes and guidelines. 通用技能: 会操作办公软件，如word、Excel等。能撰写文档、流程和指引。 • Technical skill: Familiar with biochemistry, microbiology, virology, physical chemistry. Familiar with pharmaceutical regulations, such as GMP, etc. 专业技能: 熟悉生物化学、微生物学、病毒学、物理化学知识。熟悉制药法规，如GMP 等。 • Education: Full-time college degree or above 教育背景: 全日制专科以上学历 • Languages: The English level is average and can understand simple English documents. 语言要求: 英语水平一般，能看懂简单的英语文件。