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QA-GLP QA审查员(J25219)

WuXi AppTec · 江苏省·苏州市

Imported listingfull-time8 days ago

About The Role

  1. 对研究、设施、流程、系统及供应商进行检查/审计，将观察结果报告给管理层，并为所负责的研究/项目建立完整的检查/审计档案；
  2. 安排并执行质量保证活动的检查；
  3. 审核研究方案、最终报告及相关修订内容，并为所有GLP区域的最终报告准备QAU声明；
  4. 审查生产线的标准操作规程是否符合GLP法规要求；
  5. 维护质量保证记录和主计划，并实施和支持质量趋势分析。
  6. 自然科学专业学位或具有同等相关的从业经验；
  7. 良好的人际交往及沟通（书面和口头）能力；
  8. 良好的英语书面及口语理解能力；
  9. 对监管（GLP）要求的理解；
  10. 具备计算机化系统验证方面的经验则更佳

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