QA Aitant 分享到：0
拜耳医药保健有限公司
公司介绍招聘职位公司平均工资(12500元)评价工作环境
工作地点：广东广州市 | 学历要求：本科以上 | 工作经验：0-2年 | 职位类型：全职 职位职能:
药品生产/质量管理
职位描述: 工作地点：广州工厂
Major tasks and responsibilities of position 主要工作及职责
1.To implement the executed Batch Record Review and Analysis Report Review in a defined deadline to support the product release smoothly.2.To implement executed Batch Record Scan and Analysis Report Scan in a defined deadline to support the documents filing smoothly.3.To implement downloading and uploading Electronic Supervision Barcode in a defined deadline to support the documents filing smoothly.4.To arrange and implement the effective management of Technical Registration Doier such as release specification / test procedure, MD and MBR in an accurate, timely and organized manner in order to ensure the valid versions are used in the right time and the right place.5.To involve in Production on-site monitoring to ensure Quality system smoothly.6.To implement Annual product review; handle internal product technical complaints in time to improve the quality of products.7.To handle the other GMP or QA related documents to ensure Quality system smoothly.8.Performs the other work aigned by the supervisor in a positive manner in order to ensure smooth and efficient operation.1.在规定期限内审阅已执行批记录和检验文件以保证产品的正常放行。 2.在规定期限内扫描已执行批记录和检验文件以保证文件的正确归档。 3.在规定期限内下载和上传电子监管码以保证物料和产品的正常放行。
4.有效管理当地技术文件如放行标准，检验规程，工艺规程和基准批记录等以保证现行版本的正确使用。
5.参与生产部现场监控确保质量体系的正常运作。
6.完成年度产品回顾；及时处理产品的内部投诉以提高产品质量。 7.处理其它与GMP 或QA 相关文件确保质量体系的正常运作。 8.正确执行上级安排的其他工作以保证这些流程的正常和有效运作。 Qualifications 资历
Education 教育: BS Degree graduate or above in pharmacy or related major 药学或相关专业大学本科以上学历
Experience 经验: 1 year and above related experience in pharmaceutical plant preferred 一年以上药厂经验优先考虑
Specialised Training 专业培训: GMP/regulations, Medical, Pharmaceutics and related speciality GMP 和GMP相关的国内外法律法规
Knowledge & Skills 知识和技能: Knowledge of GMP standards and related national /international regulations and quidelines GMP 熟悉和GMP相关国内外法律法规
Knowledge of production proce and quality control 了解药品的生产和质量控制
Spoken and written English reach CET-4 英语口语和书写达到CET-4 Good coordination and communication skill with others 良好的协调和沟通能力 Patient and careful 耐心细致
Good at computer operation良好的计算机操作水平
