质量保证体系专员/助理
质量保证体系专员/助理
8.4-11.2万
苏州工业园区 | 无需经验
发布时间:2021-09-04 13:20 | 截止时间:2022-12-31
基本信息:
  • 生物工程/生物制药
  • 应届毕业生
  • 全职
  • 3
  • 质量部门
  • 质量经理
职位描述及要求:
  • Quality Assurance 质量要求
    • Write, review documents in Chinese and English to establish and maintain efficient operation of the Company’s Quality Management System to encompass general operations, product development, and medicinal product manufacturing and testing (primary focus on medicinal products);
    用中英文起草,审核文件,建立和维护公司质量管理体系的运营,包括通用管理、产品开发、产品生产及检验(关注在药品);
    • Support Continuous Improvement for Quality Management system;
    为质量管理体系的持续改进提供支持;
    • Support the system for management of supplier quality related to medicinal products;
    为与药品相关供应商的质量管理提供支持;
    • Ensure consistency and alignment between documents in compliance with SOP requirements;
    保证文件之间的一致性以符合SOP的要求;
    • Provide expertise and leverage best practices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps;
    当审核草稿文件和批记录或表单时,为技术和支持团队提供专业意见;
    • Directs and leads the efforts of others to ensure the timely implementation of documents;
    领导并保证文件能够及时完成;
    • Support material release and material management system;
    参与物料放行和物料管理体系;
    • Challenge system and look for areas of improvement to increase efficiencies and decrease document cycle times;
    挑战系统并寻找可以提升工作效率、减少文件周期时间的区域;
    • Review changes, deviations, risk assessments, corrective actions, and proposed preventative actions related to product quality. Administer the program to evaluate the effectiveness of changes;
    审核产品质量相关的变更、偏差、风险评估、纠正预防措施。管理相应程序评估变更的有效性。
    • Support program of periodic quality reviews including regular meetings and at least annual written reports。
    支持质量周期性审核包括定期会议和年度报告。

    Qualifications 任职资格
    • B.S. (preferably Biology or Chemistry)
    本科(优先生物或化学专业)


岗位条件:
  • 本科
  • 英语 熟练
  • 医药卫生类>制药工程
  • 不限
您也可以使用手机扫描二维码分享这个职位给朋友们
  • 私营企业
  • 制药/生物工程
  • 苏州大道西119号苏悦商贸广场南楼20层2005
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