苏州
5人
全职
职位类别:
Conduct inspections/audits of studies, facilities, processes, systems and vendors, report observations to management, and maintain complete inspection/audit files on assigned studies/projects; 2. Schedule/conduct inspections of QA activities; 3. Audit study protocols and final reports and associated amendments and prepare QAU statements for final reports within all GLP areas; 4. Review line function SOPs for compliance with GLP regulations; 5. Maintain QA records and Master Schedule and implement and support QA trend analysis. 任职资格:1. Degree in Natural Sciences or comparable related experience; 2. Good interpersonal and communication (written and oral) skills; 3. Good understanding both written and oral of English language; 4. Understanding of regulatory (GLP) requirements. 5. Have computerized system validation experience is better;
专业要求:生物科学及生物技术类
江苏省苏州市吴中区苏州市吴中区吴中大道1318号
苏州药明康德新药开发股份有限公司
行业: 制药/生物工程 规模: 100-200 性质: 私营·民营企业 当前职位: GLP QA Auditor(质量保证审计员)
苏州药明康德通过赋能全球制药、生物科技和医疗器械公司,药明康德致力于推动新药研发进程,为患者带来突破性的治疗方案。本着以研究为首任,以客户为中心的宗旨,药明康德通过高性价比和高效的研发服务,助力客户提升研发效率,服务范围涵盖化学药研发和生产、细胞及基因疗法研发生产、医疗器械测试等领域。目前,药明康德的赋能平台正承载着来自全球 30 多个国家的 4000 多家合作伙伴的研发创新项目,致力于将更多新药、好药带给全球病患,早日实现“让天下没有难做的药,难治的病”的愿景。
私营·民营企业
100-200人