QA专员

面议

浙江省

刷新时间：2023-02-06

职位描述

  QA 高级专员

职责描述：

1.     质量管理体系Quality Management System

• 负责文件管理和控制 Responsible for documentation management and control

• 负责档案管理 Responsible for archiving management

• 负责GxP培训体系、协调培训执行和人员资格确认 Responsible for GxP training system, coordinate training implementation and personnel qualification

• 参与阶段相适应的质量体系搭建 Participate in the establishment of Quality Management System as phase appropriate

• 负责质量情报管理（包括法规、行业实践和差距分析，等） Responsible for quality intelligence （regulation， industry practice and gap analysis, ect.）management

• 参与变更控制和分配的CAPA管理活动 Participate change control and CAPA management as assigned

• 参与供应商管理和审计活动 Participate in supplier management and audit

• 日常巡检以确认GGRP（良好数据和记录管理规范）合规性 Floor inspection to check GDRP compliance

• 培训、支持其他部门的文件管理员和培训协调员 Train and support the document & training coordinators

2.     质量运营Quality Operation

• 需要时，参与现场监督和支持 Participate in on-site monitoring and support when required

• 需要时，参与批记录审核 Batch record review when required

3.     确认与验证管理Qualification & Validation

• 参与验证与确认工作(例如，审核验证方案、报告；更新验证管理文件；建立维护VMP等) Support qualification or validation activities （e.g. review validation protocols and reports; update validation relevant procedures; establish and maintain VMP, etc.）

• 参与验证文件的归档 Participate in archiving the validation documents

4.     其他直线经理分配的工作Other tasks assigned by line-manager

 

任职要求：

• 药学、生命科学相关专业本科及以上学历 BS or above in pharmacy, life science or related field

• 两年以上无菌/生物药质量保证工作经验，有基因细胞治疗产品经验优先。 2+ years experience in sterile drug/biologics quality assurance, experienced in GCT products is preferred.

• 了解设施、设备、仪器、工艺、分析方法和计算机化系统验证者优先。 Familiar with in facility, utility, equipment, instrument, process, analytical method and computerized system validation, is preferred.

• 有QMS系统（例如文件系统、培训系统、Trackwise 系统等）经验优先。 Experienced in QMS systems (e.g. documentation management system, training management system, trackwise system, etc.), is preferred.

• 熟悉GMP运营原则要求和实践执行 Familiar with GMP operational principles and practices.

• 独立、自我驱动和结果导向的工作方式 Works independently, self-motivated, and results oriented

• 在日常运营场景中，有良好的英语阅读和理解能力 Good command of English in reading and comprehension at operational level

• 有NMPA/US FDA/EMA GMP认证经验者优先 Experienced in NMPA/US FDA/EMA compliance requirements for cGMP, is preferred

其他要求

招聘人数：2人
职能类别：QA总监/QA经理/QA主管

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。