锦鲤求职岗位描述
岗位职责：1、负责XDC生产的日常检查和现场监控，确保各项工作按SOP及指定批记录执行。Responsible for routine inspection and onsite monitoring of XDC production area, to ensure all GMP activities are carried out according to SOP and specified MBR.2、负责审核与XDC生产相关的质量文件。Responsible for reviewing XDC production related quality documents.3、负责审核XDC 生产产生的有关记录。 Responsible for reviewing XDC production related records.4、负责审核偏差、变更和纠正预防措施。Responsible for reviewing the deviation, change control and CAPA.5、负责项目QA FL相关工作。Responsible for project quality management as QA FL.6、承办领导交给的其他任务。Deal with other projects/tasks assigned by manager. 7、需要翻班。 Need shift. 任职要求：1、 教育背景：医药相关专业，本科学历及以上Medical related major, bachelor's degree or above 2、 经验要求：2年以上工作经验2 years or above work experience 3、工作技能：了解FDA/中国/欧盟法规及ICH等的要求Understand FDA/China/EU and ICH GMP requirements了解熟悉无菌药品生产Understand and acquaint sterile pharmaceutical production 了解mAb生产过程Understand mAb production良好的沟通协作能力Good communication and coordination skills良好的计算机办公技能Good computer skills4、 语言要求：良好的英文听说读写能力尤佳 Perfect for good English listening, speaking, reading and writing skill