长沙招聘

职位描述：
Key Accountabilities
1.Responsible for PDS validation and calibration work including equipment validation, cleaning validation or verification, computer validation, facility and utilities validation.
2.Manage project timeline to ensure new facility and equipment installed and qualified according to schedule.
3.Responsible for writing and reviewing qualification protocols, reports, validation SOPs and GMP documentations in compliance with the requirement of EU, FDA and CFDA
4.Manage all qualifications work and calibration work to ensure qualification/calibration activities follow protocols, GMP regulation or guidance requirement.
5.Responsible for VMP, validation annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning.
6.Responsible for internal audit and external audit related to qualification and calibration.
7.Expertise in validation/calibration area, demonstrate the capability to fulfill the work assignment of high quality
Be able to work in a team environment and manage the work assignment by interacting closely with colleagues and by developing cooperative working relationships with other personnel inside the company.

Qualification Requirements
1Education：BS or Master degree in pharmaceutical or engineering
2Experience and Knowledge：at least eight years work experience in validation area of pharmaceutical industry and with three years experience of managing validation team
3Abilities：Good English skills including writing, reading and oral.
4Other Requirements：Has good experience on project management for new GMP facility commissioning and qualification, and has a good record of passing FDA, EMA or CFDA inspection. 举报 分享

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。