天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津药品生产/质量管理招聘

GLP QA Compliance Auditor(J10864)

上海药明康德新药开发有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2019-09-28
  • 工作地点:上海-浦东新区
  • 招聘人数:5人
  • 工作经验:无工作经验
  • 学历要求:招5人
  • 语言要求:不限
  • 职位月薪:0.6-1.5万/月
  • 职位类别:药品生产/质量管理

职位描述

工作职责:

1. Participate in facility-based/process inspection and contractor/vendor audit;

2. Conducting study related audit; include plan/protocol review, experimental phase inspection, data audit and report audit, and issue the audit report timely;

3. Conduct audit on the computerized system when necessary;

4. Report any significant problems which are likely to affect the integrity of a study immediately to the study director, principal investigator (PI), and laboratory/ facility management (as appropriate);

5. Assist and advise QA management on quality system improvement;

6. Assist inspections by client or regulatory agency when necessary;

7. Maintain QA documentation when necessary (e.g., org chart, study master schedule, trendy analysis) when necessary;

8. Support other Quality Management System (e.g., CLIA/CAP) when necessary;

9. Review GLP SOPs when necessary.

任职资格:

1. BS degree or above in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience

2. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements

3. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives

4. Be skillful at reading, understanding and writing English documentation.

5. Working experience in QC/ QA will be plus

职能类别:药品生产/质量管理

公司介绍

药明康德是国际领先的开放式能力与技术平台公司,为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。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、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等,正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目,致力于将最新和***的医药和健康产品带给全球病患,实现“让天下没有难做的药,难治的病”的梦想。

联系方式

  • Email:zhuyun@wuxiapptec.com
  • 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
  • 电话:15738851478