QA

面议

无锡市

刷新时间：2023-03-14

职位描述

Quality Management System, inclusive of GMP standards, compliance QA GMP system, such as Master Control, Trackwise.
• Supporting all areas of the functional suites to support all GMP / GDP activities.
• This role will be accountable to manage the documentation system (Master Control) and all QMS related documents and manufacturing generated documents, including but not limited to: SOPs, batch records, deviations, CAPA, change control, QRM, etc.
• Support the periodic management review and annual product process review/CPV.
• Compiling and providing QA Metrics on a weekly, monthly, quarterly, and annual basis for Senior Management.
• Training Co-Ordinator for Quality Department and support function for all Departmental Training.
• Responsibility for GMP, GDP and QMS Training.
• Management of Documentation Archiving System.
• Other activities which are required by the Supervisor.
Person Specification
Technical Competencies
• It is desirable s/he has a knowledge of legislative, regulatory, market, and data integrity requirements.
• Strong knowledge of cGxP requirements and regulations.
• Knowledge of trouble shooting and problem solving skills; e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc.
• Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
Experience
• Strong demonstrated experience working in pharma or similar experience in a pharma/science background, and have CDMO working experience is preferable.
• Candidates from Manufacturing Operations, Validation, Engineering and other technical disciplines within the biotechnology and/or pharmaceutical industry will be considered but demonstrated experience in Quality Management System, pharmaceutical regulations and continuous/process improvement tools will be required.
• Experience in performing internal audits is ideal.

其他要求

招聘人数：1人
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。