现场质量技师 Technician PQO
深圳赛诺菲巴斯德生物制品有限公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-09-26
- 工作地点:深圳
- 招聘人数:3
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位类别:质量检验员/测试员
职位描述
KEY ACCOUNTABILITIES
关键职责
1. Familiar with the filling process of non-final sterilized products (e.g. flu vaccine); familiar with packaging line; Have the experience for production quality management on site and Familiar with the IPC of the appropriate process. Preferred: familiar with the manufacturing process for flu monovalent and final bulk; familiar with cold chain management for temperature sensitive products
熟悉非最终灭菌产品(如流感疫苗)分装工艺,熟悉包装生产线,具有生产现场质量管理经验并熟悉相关工艺的中间控制;熟悉流感原液和半成品制备工艺和温度敏感产品的冷链管理更佳。
2. Attribute and manage the review of batch records, including the review of data regarding Failure Investigation, Change Control , which are directly linked to the batch record review
批纪录审核, 包括偏差调查、变更控制等与批纪录相关的内容;
3. Capability of assessment of trouble shooting of the process, contribution to the management of the investigation, corrective action and preventive action
具有解决工艺过程问题的能力,参与调查、纠正和预防措施的管理。
4. Follow-up and ensure the compliance of the environmental monitoring of the workshop, routine follow up of the trend analysis 跟踪和确定工厂环境监控结果符合规范,趋势分析的日常跟踪
5. Follow up and trend analysis of the water system
水系统的趋势分析和跟踪
6. Participate in the preventive maintenance and qualification/validation activities
参与预防性维护及确认/验证活动。
REQUIREMENTS
任职资格
- Chinese with college qualification or above;
大学专科或以上;
- Pharmaceutical and /or biological background; workshop experience in advantage
药学或生物学背景,有药厂工作经验更优;
- Several years of related experience in similar field (production / QA);
多年相关领域(生产/QA)的工作经验;
- Computer skill: word, excel, powerpoint at least;
电脑水平:word, excel, powerpoint
- English: Oral, read and writing skill is required
英语水平:口语、读、写。
关键职责
1. Familiar with the filling process of non-final sterilized products (e.g. flu vaccine); familiar with packaging line; Have the experience for production quality management on site and Familiar with the IPC of the appropriate process. Preferred: familiar with the manufacturing process for flu monovalent and final bulk; familiar with cold chain management for temperature sensitive products
熟悉非最终灭菌产品(如流感疫苗)分装工艺,熟悉包装生产线,具有生产现场质量管理经验并熟悉相关工艺的中间控制;熟悉流感原液和半成品制备工艺和温度敏感产品的冷链管理更佳。
2. Attribute and manage the review of batch records, including the review of data regarding Failure Investigation, Change Control , which are directly linked to the batch record review
批纪录审核, 包括偏差调查、变更控制等与批纪录相关的内容;
3. Capability of assessment of trouble shooting of the process, contribution to the management of the investigation, corrective action and preventive action
具有解决工艺过程问题的能力,参与调查、纠正和预防措施的管理。
4. Follow-up and ensure the compliance of the environmental monitoring of the workshop, routine follow up of the trend analysis 跟踪和确定工厂环境监控结果符合规范,趋势分析的日常跟踪
5. Follow up and trend analysis of the water system
水系统的趋势分析和跟踪
6. Participate in the preventive maintenance and qualification/validation activities
参与预防性维护及确认/验证活动。
REQUIREMENTS
任职资格
- Chinese with college qualification or above;
大学专科或以上;
- Pharmaceutical and /or biological background; workshop experience in advantage
药学或生物学背景,有药厂工作经验更优;
- Several years of related experience in similar field (production / QA);
多年相关领域(生产/QA)的工作经验;
- Computer skill: word, excel, powerpoint at least;
电脑水平:word, excel, powerpoint
- English: Oral, read and writing skill is required
英语水平:口语、读、写。
公司介绍
深圳赛诺菲巴斯德生物制品有限公司诚聘
联系方式
- Email:Lei6.xu@sanofi.com
- 公司地址:地址:span深圳市坪山区锦绣东路25号