制剂冻干Shift Leader-Group Leader

负责制剂冻干岗位生产，包括生产实施、生产能力提升、车间GMP管理和提升、人员管理和培养、新制剂厂房建设支持、偏差、变更、风险评估、审计支持等，确保生产高质量的制剂产品。Responsible for the production of freeze-drying positions, including production implementation, production capacityimprovement, workshop GMP management and improvement, personnel management andtraining, support for new DP factory , deviation, change, risk assessment,audit support, etc., to ensure the production of high-quality DP products.在客户项目中，负责进行项目技术转移工作，协调生产工艺，使客户项目顺利完成制剂生产工作。In the client project,responsible for the project technology transfer work, coordinate the productionprocess, so that the client project can successfully product.负责部门SOP的日常维护升版。Responsible for the dailyupdating of SOP.负责组织协调部门审计工作。Responsible for organizingand coordinating the audit work of DP.负责部门的物料申领、协调工作。Responsible for the materialapplication and coordination of DP.为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。In order to keep goodproduction order, ensure the normal operation, implement the relevant staffrules, evaluate the performance of employees for effectively manage监督管理区域员工生产过程中及日常行为严格遵守EHS、IP保护等合规准则。Supervise and manage theproduction process and daily behavior of employees in the area, strictly obeyEHS, IP protection and other compliance standards.制药工程、生物工程、药学、化学或其它相关专业本科及以上学历。Bachelor or above degree inpharmaceutical engineering,biological engineering, pharmaceutics,chemical or other majors, as appropriate.了解无菌制剂专业知识，制药行业GMP专门知识，国内外药品法规。了解单抗等大分子生产。Be familiar with theprofessional knowledge of aseptic drug product, GMP professional knowledge ofpharmaceutical industry, home and abroad drug regulations.Be familiarwith the macromolecule production such as monoclonal antibody and so on.5年以上专业领域工作经验，3年以上冻干生产管理经验More than 5 years professional work experience and 3 years of freeze-drying management experience较强的管理与团队合作能力，对部门人员和各职位的工作内容有清晰的认识，能合理调配团队人员工作。Have a strong management andteam work ability, clear understanding of department staff and job content,able to deploy team members reasonably.较强的英语听说读写能力，熟练使用计算机,会操作OFFICE办公软件。Strong English listening,speaking, reading and writing ability, skilled in using computer, can operateoffice software.