上海凯莱英生物技术有限公司
供应商QA
Skills
3 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
8 August 2026
What they need
该职位来源于猎聘 岗位职责: 主导供应商审计程序,按照既定的审计计划执行审计,起草发现项报告和审计报告;
建立和维护公司供应商质量档案、合格供应商清单,收集和审核供应商资质和质量资料等。
参与供应商相关变更,负责组织供应商的审核、现场审计及供应商年度绩效评估,确保供应商符合公司的要求。 任职要求: 药学、制药工程等相关专业本科及以上学历,持有质量工程师或内审员证书者优先; 3年以上制药/医疗器械行业供应商审计或QA工作经验,具备独立完成现场审计的实操能力; 精通GMP/GDP等质量管理规范,熟悉NMPA/FDA/EU等国内外相关法规及ISO质量管理体系; 具备优秀的审计洞察力和质量风险分析能力,能独立撰写审计报告并跟踪CAPA闭环; 工作严谨细致,责任心强,坚持原则,具备优秀的沟通协调能力和抗压能力 具备良好的英语口语能力者优先。
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