QA Specialist（Senior Specialist）

面议

市辖区本科及以上

刷新时间：2018-07-03

职位描述

Work as the quality partner for production department. Generally responsible for the GMP compliance in the production department.
Review and approve process validation documents such as protocols, test records and reports.
Review and approve all SOPs in manufacturing departments and other appropriate quality related documents.
Make sure the operation compliance in the production department.

Audit and train the production team for the GMP compliance for manufacturing activities.
Review production batch manufacturing record and environment monitor record for the production area.
Work for the products release.
Deviation investigation and control.
Change request management.
Manage the CAPA actions.
Involve the relevant
Conduct the annual product quality review.
Review and approve the critical equipment maintenance and calibration plan and records.
Review and release raw materials, intermediates, packaging and labelling materials for production purpose.
Monitoring the quality KPIs.
Any other works designated by the company.
Qualification:
At least 10 years quality experiences in pharmaceutical industry, international biopharma company preferred.
Work experience with sterile drug product preferred.
University education with relevant majors such as pharmacy, chemistry etc. Master Degree Preferred.
Fluent written and spoken English.
Team spirit.

其他要求

招聘人数：1人
汇报对象：质量总监
职能类别：QA工程师

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。