EDC Validation Manager (全国)
科文斯医药研发(上海)有限公司
- 公司规模:1000-5000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:2021-01-12
- 工作地点:上海
- 招聘人数:2人
- 工作经验:2年经验
- 学历要求:本科
- 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
Any City in China (office or home based)
- Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed.
- Review EDC specifications from Lead Data Manager.
- Writes and assembles critical validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
- Provide coordination of virtual global validation teams as needed to complete validation projects.
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- Executes test cases against these requirements, enter errors in to error tracking logs and performs retests documenting resolutions, and maintain validation testing documentation and files.
- BS/BA degree preferably in the sciences or related field, or two (2) years in a validation or regulatory position dealing with SOPS and computer systems requirement specification.
- Minimum 2 years of pharmaceutical or equivalent experience.
- Minimum 2 years Validation experience or work experience in a regulated (FDA, EPA, etc.) environment preferred.
- Strong attention to detail.
- Strong analytical skills, preferably in a GCP environment.
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
- Problem Solving/Logic Skills.
- Strong communication and interpersonal skills.
- Strong MS/Office skills in particular with Excel and Word.
- Understanding of Electronic Data Capture (EDC) and the clinical trial process preferred.
公司介绍
LabCorp是全球顶尖的生命科学公司,科文斯作为LabCorp旗下的药物研发部门,肩负着改善人类健康与生命的共同使命。科文斯的实验室和设施遍布全球,在世界范围内拥有超过26000名员工,卓越的研发能力和强大的人才资源奠定科文斯在医药研发行业的领先地位。截止到2020年,科文斯中国团队共参与了近100个获得上市许可的新药研发,积极支持超过50个免疫肿瘤药物的研发项目,是服务***面的药物研发公司。
欢迎加入科文斯中国团队,我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号,通过移动端迅速查询热招职位并投递申请,与我们并肩实现#CovancePotential。
欢迎加入科文斯中国团队,我们提供优厚的薪酬、完善的培训以及灵活的办公方式。也请关注“科文斯招聘”微信公众号,通过移动端迅速查询热招职位并投递申请,与我们并肩实现#CovancePotential。
联系方式
- Email:yuanxin.fang@covance.com
- 公司地址:地址:span浦东新区伽利略路338号9号楼