Data QC Specialist 数据分析质控专员
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:2017-02-02
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:3-4年经验
- 职位月薪:6-8千/月
- 职位类别:医药技术研发人员 质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述:
1. Conduct experimental phase inspection and data audit to all studies
2. Follow up the corrective action to assure all findings are timely corrected.
3. Conduct QC review of study raw data and report.
4. Conduct facility inspection routinely to maintain consistent high level of compliance.
5. To ensure laboratory equipment and systems are suitable for use.
6. Conduct process audit for Equipments, Software, Logbook, Solutions and Reagents, Environment.
7. To ensure that records are made manually or by recording instruments which demonstrate that all the required testing procedures were actually carried out
REQUIREMENTS:
1. BS degree or above in Analytical, Biology or related field.
2. Must be trained in or have experience with the requirements of the FDA GLP regulations and OECD GLP guidelines.
3. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
4. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.
5. Must be familiar with process of bio-analytical studies.
6. Be skillful at reading, understanding and writing English documentation.
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1. Conduct experimental phase inspection and data audit to all studies
2. Follow up the corrective action to assure all findings are timely corrected.
3. Conduct QC review of study raw data and report.
4. Conduct facility inspection routinely to maintain consistent high level of compliance.
5. To ensure laboratory equipment and systems are suitable for use.
6. Conduct process audit for Equipments, Software, Logbook, Solutions and Reagents, Environment.
7. To ensure that records are made manually or by recording instruments which demonstrate that all the required testing procedures were actually carried out
REQUIREMENTS:
1. BS degree or above in Analytical, Biology or related field.
2. Must be trained in or have experience with the requirements of the FDA GLP regulations and OECD GLP guidelines.
3. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
4. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.
5. Must be familiar with process of bio-analytical studies.
6. Be skillful at reading, understanding and writing English documentation.
职能类别: 医药技术研发人员 质量管理/测试工程师(QA/QC工程师)
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