QA specialist/auditor
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:2013-06-20
- 工作地点:上海-浦东新区
- 招聘人数:1
- 工作经验:一年以上
- 学历要求:本科
- 语言要求:英语熟练
- 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
Responsibilities:
1.Quality assurance the Bioanalytical study in compliance with FDA, OECD, SFDA and GLP regulations, including the raw data and reports generated from LC-MS/MS methodology and Biomarker assay.
2.Assure lab operations are in compliance with 21CFR part 11
3.Audit the experiment operation based on specific study requirement and GLP regulations.
4.Regular inspection of lab operations including facility, instruments, computers and documentation.
5.Timely communication with analysts, study director, principal investigator and management.
6.Summarizing and sharing findings found in protocol audit, phase audit and report audit
Requirements:
1.Proficient English skills in reading, writing and speaking, able to work in an English environment.
2.Bachelor degree or above with background in Chemistry, Biology, Pharmacy or related science field.
3.Work experience with GLP, GMP or GCP
4.Able to work in a precise, logistic and efficient manner.
5.Good communication skills.
6.Excellent cooperation skills and team spirit.
7.Able to work under pressure.
1.Quality assurance the Bioanalytical study in compliance with FDA, OECD, SFDA and GLP regulations, including the raw data and reports generated from LC-MS/MS methodology and Biomarker assay.
2.Assure lab operations are in compliance with 21CFR part 11
3.Audit the experiment operation based on specific study requirement and GLP regulations.
4.Regular inspection of lab operations including facility, instruments, computers and documentation.
5.Timely communication with analysts, study director, principal investigator and management.
6.Summarizing and sharing findings found in protocol audit, phase audit and report audit
Requirements:
1.Proficient English skills in reading, writing and speaking, able to work in an English environment.
2.Bachelor degree or above with background in Chemistry, Biology, Pharmacy or related science field.
3.Work experience with GLP, GMP or GCP
4.Able to work in a precise, logistic and efficient manner.
5.Good communication skills.
6.Excellent cooperation skills and team spirit.
7.Able to work under pressure.
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