细胞库现场QA/CB QA

关键职责Key Responsibilities 负责QA部门相关文件的起草和修订； Responsible for drafting and revising documents related to the QA department 负责CB部门主生产记录、批生产记录以及电子数据的审核； Responsible for reviewing master production records, batch production records and electronic data for the CB departments 负责CB部门生产现场的日常监控； Responsible for daily monitoring of production sites for the CB departments 参与CB异常情况调查、处理，审核以及批准，纠正预防措施计划并监督实施，以及完成后必要的有效性检查 Participate in investigation, handling, review and approval of deviations/abnormal events in the CB departments; develop corrective and preventive action (CAPA) plans, supervise their implementation, and perform necessary post-implementation effectiveness checks; 参与项目相关问题的协调与处理 Participate in coordination and resolution of project-related issues 配合内审和外部检查相关工作； Support internal audits and external inspections

Job Requirement 具备医药或相关专业教育背景 无菌相关知识和经验 敏锐的观察力，敢于挑战，敢于进取，能够高效的完成所安排的工作; Strong observational skills; proactive, willing to take on challenges, and able to complete assigned tasks efficiently 了解GMP/cGMP/欧盟GMP等法规； Knowledge of GMP/cGMP/EU GMP regulations 良好的沟通协调能力； Good communication and coordination skills 具有基本的英文交流能力，听说读写 Have basic English communication skills(listening, speaking, reading and writing) 熟悉DS&CB生产过程及相关法规要求 Familiar with CB production processes and related regulatory requirements 善于发现问题，并具备学习热情 Able to identify problems and eager to learn