分析研究组长

到岗时间：不限 年龄要求：不限 性别要求：不限 婚况要求：不限 1. 确保在分析方法的开发、确认与验证、以及执行过程中的合规，满足中国药监局相关法规要求及其他GMP法规要求Assure in-compliance in analytical development, verification an d validation, an d execution, according to NMPA regulations an d GMP requirements. 2. 在经理的指导下，全面管理整个项目的质量研究工作。Under the supervision of line manager, to manage quality research work of whole project. 3. 作为项目分析负责人，与工艺开发团队合作，分析方法的开发、并一起制定控制策略As analytical project leader , to develop analytical methods to support process development, an d to define the control strategy. 4. 能够设计方案并进行分析方法的转移、确认与验证，包括文档工作（方案、批记录、报告）和执行 Design the protocol an d implement the transfer, verification an d validation of analytical methods, including both good documentation （protocols, analytical batch record, reports） an d execution of lab work. 5. 作为组长，培训、指导和管理小组分析研究员的日常工作，实现各项目目标。As group leader, to train, monitor an d manage analytical scientists in regular work to achieve project targets. 6. 负责相关的变更与偏差管理To be responsible for related change control an d deviation management. 7. 对分析仪器的日常管理与维护 Regular operation an d maintenance of analytical instruments. 教育背景 Education Requirements 大学本科或以上学历，分析化学、化学、药学等相关专业，本科至少5年，硕士至少3年以上的分析相关工作经验 BS Ｏr above in Analytical Chemistry, Chemistry Ｏr Pharmaceutical Chemistry with 5 years for BS Ｏr 3 years for MS of working experience. 其他需求 Other Requirements 1. 积极向上，乐于学习；团队合作，服务意识Work with passion. Tend to learn for self-improvement. Be team player with service consciousness. 2. 熟悉中国药典、USP、欧洲药典，及ICH, FDA, EMA法规要求Be familiar with Ch. P, USP, Ph.Eur. , an d ICH, FDA, EMA regulatory requirements. 3. 良好的英语书写交流能力Good writing an d communication skills in English. 4. 精通HPLC和GC操作，并具备很强的分析方法开发能力。Master with HPLC an d GC operation, an d be strong in analytical method development.