岗位职责JD： 1、 Conduct external supplier audit as required by the company 按照公司的要求进行外部供应商审计 2、 Have ability to complete external supplier audit independently after training 经过培训后能够独立完成外部供应商审计 3、 Conduct pre-audit communication according to audit requirements and make audit arrangements 根据审计要求进行审计前沟通，确定审计安排 4、 Conduct on-site audit according to audit requirements 按照审计要求进行现场审计 5、 Adhere to audit requirements, complete audit report, CAPA audit, audit closure and so forth. 按照审计要求完成审计报告、CAPA审核和审计关闭等工作 6、 Maintain and ensure that suppliers are in approved status 维护并确保供应商处于批准状态 7、 Complete other tasks assigned by leaders 完成领导交代的其他事情 任职需求： 1、 Good English reading and writing skills, fluent oral English is preferred 有较好的英语读写能力，有良好的英语口语沟通能力优先 2、 At least 2-years working experience in System QA or production process management or QC department management 至少2年以上的体系QA或生产工艺管理或QC部门管理的工作经验 3、 Familiar with GMP or relevant regulations, FDA, EU and other quality related regulations 熟悉GMP或相关规定，熟悉FDA，EU等质量相关法规 4、 Bachelor degree or above in Pharmacology related field 药学相关专业本科或以上学历 5、 Good problem solving and analytical skills 良好的问题解决和分析能力 6、 Good at communication and Decision Making; 良好的沟通技巧和决策能力； 7、 Planning/Organizing with effective Communication Teamwork 通过有效的沟通和团队合作进行规划/组织