QA supervisor ,Biology
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000人
- 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:2019-09-05
- 工作地点:北京-昌平区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:硕士
- 职位月薪:1-1.5万/月
- 职位类别:生物工程/生物制药
职位描述
1. Perform QC test records review to support DS/DP release
2.Manage quality events during drug supply and distribution process (Biologics temperature excursion, Complaint, Deviation, CAPA, etc.)
3.Review technical document and provide interpretation if needed to support biologics clinical studies
4. Manage vendors to support biologics early development
5.Perform quality assurance activities, such as improve GLP/GMP quality system, perform internal audit, coordinate QC quality events investigation, etc.
Qualification:
1. A master’s degree in Biology, Biochemistry, Medicine or equivalents, with more than 3 years working experience in Biologics QA/QC.
2.Familiar with GDP, DI, GLP and/or GMP requirements.
3.Familiar with general biology laboratory techniques and antibody techniques, have experience and knowledge in some of below technologies (e.g., PCR, cell culture, flow cytometry, western blot, ELISA, SDS-PAGE, Capillary electrophoresis, SPR, HPLC and LC/MS)
4. Have a good attention to details.
5.Good communication skills in both Chinese and English.
6.Team player with flexibility, responsibility and hard work spirit.
职能类别:生物工程/生物制药
公司介绍
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)