长沙招聘

工作职责:

1. Conduct facility inspection, special inspection, computerized system audit, vendor/contractor audit, etc., and review SOP when necessary.

2. Conduct study-based audit; including plan/protocol review, experimental phase inspection, data audit, report audit and report verification etc.

3. Promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable; Follow up implementation of CAPA, when applicable.

4. Assist inspections by client or regulatory agency when necessary.

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

6. Assist to schedule/conduct inspections of QA activities.

7. Support other quality systems out of BAS test facility when necessary.

8. Conduct work described in the related SOPs and according to OECD, FDA and CFDA, etc., GLP guidelines as well as other applicable regulations.

9. Work with QA management to lead the group to support the GLP, etc., program.

10. Work with QA management to develop strategic plan and execute the plan for the development of QA department.

11. Conduct the work delegated by QA management.

任职资格:

1. Have the ability to understand the basic concepts underlying the activities being monitored. Have a thorough understanding of the Principles of GLP.

2. Be familiar with the test procedures, standards and systems.

3. Be trained or have expertise and experience with the requirements of the OECD, FDA and CFDA, etc., GLP guidelines as well as other applicable regulations.

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

5. Have good communication skills, both written and verbal, and work in a team-oriented manner.

6. Have good leadership and working experience in Quality management.

7. BS, MS or Ph.D. degree in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience.

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。