验证专员
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：2017-04-04
- 工作地点：上海-浦东新区
- 招聘人数：2人
- 职位月薪：6-9千/月
- 职位类别：药品生产/质量管理
职位描述
职位描述：
Key accountabilities:
? Responsible for generating and monitoring of VMP, and maintaining and improving of validation system
? Responsible for writing and reviewing the qualification protocols, reports, operation SOPs and GMP documentations in compliance with the requirement of EU, FDA and SFDA
? Perform the execution of qualifications, cleaning validation and maintenance of validation equipment.
? Responsible for validation annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning
? Support the activities of facility’s design, commissioning and qualification, and review the related documentations
? Assist internal and external audit, write response report and follow up the corrective actions to ensure the actions complete timely
? Provide validation and SOP trainings.
? Be accountable and demonstrate good working ethics, integrity, ownership and leadership.
Scope of the job:
? Complete all the qualification document, SOPs and GMP related documentation on a timely manner.
? Conduct the work assignments in compliance with cGMP regulations whenever applicable.
? To communicate with and assist different group or department in a timely manner to fulfill the work assignment of high quality and efficiency.
? Depending on the focus area and individual expertise, demonstrate the capability to fulfill the work assignment of high quality.
? Be able to work in a team environment and to complete the work assignment by interacting closely with colleagues and by developing cooperative working relationships with other personnel inside the company.
Core skills and education:
BS or Master degree in pharmaceutical or engineering, at least three years work experience in validation area of pharmaceutical industry.
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Key accountabilities:
? Responsible for generating and monitoring of VMP, and maintaining and improving of validation system
? Responsible for writing and reviewing the qualification protocols, reports, operation SOPs and GMP documentations in compliance with the requirement of EU, FDA and SFDA
? Perform the execution of qualifications, cleaning validation and maintenance of validation equipment.
? Responsible for validation annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning
? Support the activities of facility’s design, commissioning and qualification, and review the related documentations
? Assist internal and external audit, write response report and follow up the corrective actions to ensure the actions complete timely
? Provide validation and SOP trainings.
? Be accountable and demonstrate good working ethics, integrity, ownership and leadership.
Scope of the job:
? Complete all the qualification document, SOPs and GMP related documentation on a timely manner.
? Conduct the work assignments in compliance with cGMP regulations whenever applicable.
? To communicate with and assist different group or department in a timely manner to fulfill the work assignment of high quality and efficiency.
? Depending on the focus area and individual expertise, demonstrate the capability to fulfill the work assignment of high quality.
? Be able to work in a team environment and to complete the work assignment by interacting closely with colleagues and by developing cooperative working relationships with other personnel inside the company.
Core skills and education:
BS or Master degree in pharmaceutical or engineering, at least three years work experience in validation area of pharmaceutical industry.
职能类别： 药品生产/质量管理
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