职位详情
QA Specialist-GSP
1-2万
诺和诺德(上海)医药贸易有限公司
北京
1-3年
本科
06-05
工作地址

利星行中心

职位描述
Key responsibilities 重要职责
Quality management system-GSP related.GSP相关质量管理体系
RDC received products confirmation RDC收货确认
Distributors management 经销商管理
Main job tasks 主要工作任务
1) Quality management system-GSP related
 GSP related QMS maintenance, e.g. CR, SOP and training.GSP相关的质量体系维护,例如:变更,SOP和培训
 GSP L1 distributors quality management. 一级经销商的质量管理
 Prepare and attend GSP inspection internal/compliance check.准备并参加GSP审计和内部合规性评估
 Review and approve transportation validation related documents. 评估并批准运输验证相关文件
 Master data approval 主数据批准
 Other tasks assigned by line manager其他直线经理安排的工作
2) RDC received products confirmation
 Review and confirm receiving documents from RDC.评审并确认RDC收货文件
 Temperature records evaluation.运输温度评估
 Handling product damage, deviation etc.处理产品损坏,偏差等
3) Distributors management
 Distributors management, including qualification assessment, authorization review and approval, license archiving, information collection etc 经销商资质评估,授权批准,证照归档,信息收集等
Education 教育背景
• Bachelor degree in pharmaceutical or related area
• Good English communication skills in both written and spoken
Experience 经验
• At least 2 year working experience in quality in pharmaceutical companies
• Broad knowledge is needed (Drug regulation, familiar with basic processes in relat-ed department)
Personal skills 技能
• Good communication, cooperation and networking skills with internal & external stakeholders (most of the work need communication internally & externally)
• Be of strong sense of responsibility, patient and initiative
• Mature, independent, and team spirit

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