长沙 [切换城市] 长沙招聘长沙质量管理/安全防护招聘长沙质量管理/测试工程师(QA/QC工程师)招聘

QA专员- GMP 质量管理部

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:2015-04-25
  • 工作地点:上海-浦东新区
  • 招聘人数:1
  • 学历要求:大专
  • 语言要求:英语
  • 职位月薪:面议
  • 职位类别:药品生产/质量管理  质量管理/测试工程师(QA/QC工程师)

职位描述

1.Be responsible for conducting production on-site inspection and in-process control.
2.Be responsible for ensuring that raw materials, packaging materials and intermediate, bulk and finished product are approved or rejected according to defined procedure or specification, manage retain sample.
3.Be responsible for reviewing batch record and ensuring related operation and documentation is in compliance with defined procedures.
4.Be responsible for coordinating deviation to ensure corrective and preventative actions are carried out and documented.
5.Be responsible for coordinating change control to ensure any changes are documented according to defined procedure.
6.Be responsible for taking part in investigation, documentation and communication of GMP nonconformity.
7.Be responsible for conducting internal audit and routine inspection.
8.Be responsible for QA related SOP’s writing, revision and reviewing.
9.Be responsible for providing GMP/quality assurance related training.
10.Be responsible for periodical quality evaluation with other departments
11.Any jobs and responsibilities assigned by QA leader.

Requirement:
1.Should have two years above experience on GMP quality assurance in pharmaceutical industry
2. Should be trained or have experience on SFDA, FDA, EMEA GMP regulation.
3. College degree or above in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience.
4. Strong communication skills, both in writing and speaking, and outstanding interpersonal skills are essential to job requirements.
5. Should be able to share information openly and work in a team-oriented manner to accomplish performance objectives.

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