GLP QA(2019应届生)
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:2019-06-01
- 工作地点:上海-浦东新区
- 招聘人数:3人
- 工作经验:无工作经验
- 学历要求:招3人
- 语言要求:不限
- 职位月薪:0.6-1.5万/月
- 职位类别:药品生产/质量管理
职位描述
工作职责:
1. Participate in facility-based/process inspection and contractor/vendor audit;
2. Conducting study related audit; include plan/protocol review, experimental phase inspection, data audit and report audit, and issue the audit report timely;
3. Conduct audit on the computerized system when necessary;
4. Report any significant problems which are likely to affect the integrity of a study immediately to the study director, principal investigator (PI), and laboratory/ facility management (as appropriate);
5. Assist and advise QA management on quality system improvement;
6. Assist inspections by client or regulatory agency when necessary;
7. Maintain QA documentation when necessary (e.g., org chart, study master schedule, trendy analysis) when necessary;
8. Support other Quality Management System (e.g., CLIA/CAP) when necessary;
9. Review GLP SOPs when necessary.
任职资格:
1. BS degree or above in a science discipline with experience or training in chemistry, pharmaceutical, or equivalent experience
2. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements
3. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives
4. Be skillful at reading, understanding and writing English documentation.
5. Working experience in QC/ QA will be plus
职能类别: 药品生产/质量管理
公司介绍
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