上海招聘

职位描述：
岗位职责：
1、负责纯水、注射用水和纯蒸汽设备及分配系统的验证；
2、撰写工厂验收测试、现场验收测试、风险评估、验证计划，验证方案(DQ，IQ，OQ）；
3、负责收集验证中发现的问题、缺陷，并提出改进措施，通知相关部门整改，确认整改结果；
4、参与验证过程中的偏差、变更处理；
5、负责验证文件档案管理；
Responsibilities:
1.Perform Purified Water generation system, WFI generation system and pure steam generator and distribution system's validation and qualification;
2.Prepare Factory Acceptance test, site acceptance test, risk assessement, validation plan and validation protocol(DQ,IQ,OQ);
3.In Charge of collecting problem and defectives during qualification and propose corrective measure, notice related department to rectify and confirm the result;
4、Take part in deviation and change during qualification process;
5、In charge of validaiton documents sorting out and archive.
任职资格：
1、本科以上学历，工程、生命科学或生物相关专业；
2、一年以上制药行业质量、技术或者验证工作经验
3、掌握GMP法规、ISPE 和验证方法优先；
4、熟练的英语书面及口语能力，能用英文流利交流；
5、具有良好的沟通协调能力，高度的细节关注能力和在压力下工作；
6、熟悉基本的电脑软件工具，如文字处理和电子表格
7、愿意高强度出差
Job Requirement:
1、Bachelor degree in engineer or life science or biological;
2、1+ years of work experience in quality,technical or validation of pharmaceutical industry;
3、Knowledge of GMP regulations, ISPE and validation methods is preferred;
4、Excellent English both in writing and orally
5、Good communication skill，Good practice in attention to details and work in high pressure;
6、Familiar with basic PC software tools, including Microsoft word and Excel
7、Willing to travel intensively 举报 分享

制药和生命科学行业
交钥匙解决方案的理想合作伙伴
 
水广泛用于制药和生命科学行业。不同的水处理工艺都需符合官方法定药典定义标准。大多数工艺流程都需要使用能够满足药典规定标准的水和其他洁净介质。倍世水技术 提供了从原水到终端使用点的制药供水系统。此外，我们还提供包括溶液制备、在线清洗/在线灭菌以及污水灭活的整套无菌生产系统。
 
作为制药行业的领先供应商，倍世水技术拥有多年丰富的行业经验，并凭借各种等级水处理以及废水处理的整套技术，满足生产研发与生产环境的要求。

我们位于欧洲、亚洲以及美国的制造工厂能够提供各种设备、机架式集成系统、水罐和容器。倍世水技术可供应各种重要组件，例如我们自己生产的容器、设备管道系统的轨道焊接、软件编程以及控制面板制造。此外，倍世水技术是欧洲EDI电去离子模块的***供应商。我们独特的专利卷式EDI模块SEPTRON®成为许多先进水处理工艺系统的核心组件。

倍世水技术（上海）有限公司
2004年，倍世水技术（上海）有限公司在中国成立，成为倍世水技术集团的分支机构。专业提供高品质的水处理系统和整体解决方案，目前已在中国国内和海外成功完成60多个项目。倍世水技术（上海）有限公司工厂位于上海青浦。交通便利，离上海虹桥国际机场仅有三十分钟的路程。拥有40多位经验丰富的专家，为制药领域的用户提供设计，制造，调试和验证服务。
我们的供货范围包括预处理系统，多介质过滤装置/活性碳过滤装置和超滤设备，OSMOTRON-RO/EDI系统，MULTITRON-WFI注射用水系统，VAPOTRON纯蒸汽发生器和COMBITRON注射用水与纯蒸汽生产组合系统。同时，我们还提供LOOPO分配系统（热水或臭氧消毒）以及相关的分配管道安装服务。所有产品都来自我们当地团队的设计和制造，并得到欧洲团队的鼎立支持和协作。每一个焊工都按EN标准通过权威机构认可。倍世水技术（上海）有限公司致力于成为包括完整验证系统服务的交钥匙工程的首选供应商。

市场与合作伙伴
在项目执行上，我们的合作伙伴包括:制药制造商，制药厂房设计院，和大型***的专业工程管理公司。我们的客户包括 AstraZeneca、Sanofi-Aventis、Boehringer Ingelheim、Eli Lilly、Glaxo Smith Kline、Novartis、Novo Nordisk、Pfizer、Roche、Bayer-Schering 以及 Merck-Serono。

Partner for Turnkey Solutions
in the Pharma & Biotech Industry
 
Water is the most widely used material within the Pharma & Biotech Industry. Most processes require water and other clean media which meets legal standards defined in pharmacopoeias. BWT Pharma & Biotech provides systems of pharmaceutical water from the feedwater supply to the point-of-use. Furthermore, we offer complete sterile manufacturing systems including
solution preparation, CIP/SIP and wastewater inactivation.

As a leading supplier to this market, BWT Pharma & Biotech has many years of experience and possesses a comprehensive spectrum of technologies for producing
all the grades of water required in R&D and production environments as well as handling the waste produced.


Our manufacturing facilities in Europe, Asia and the United States provide equipment, skid mounted systems, tanks and vessels. BWT supplies key components such as vessel manufacture from own production, orbital welding of pipework for equipment, software programming and control panel manufacturing. Furthermore, BWT Pharma & Biotech is the only European supplier of EDI modules. The unique, patented EDI spiralwound module SEPTRON？ is the core component of many modern water treatment systems.


Understanding Project Execution
To achieve a consistent level of solid Project Execution you must first of all understand the customer and project demands at tender stage. Evaluating the information
and providing the best solution to meet the project and customer demands encompasses all aspects of the project from specifications, drawings, programme and budgets to conditions of contract, etc. When all this is evaluated correctly at tender stage, experience dictates that projects are executed harmoniously, on time and within budget. It is our aim to work with our customers as partners.


After all we all want the same thing – a successful project, constructed on time and within budget. As partners we introduce our Key Performance Indicators which are our
joint mechanism for monitoring all aspects of the project on a regular basis. This allows senior management of both companies to monitor and influence the success of the project. We continually work with our customers, ensuring that their requirements and expectations are met in line with the project programme.


Markets and partners
Projects are carried out in partnership with pharmaceutical manufacturers, pharmaceutical plant designers and other specialist leading engineering companies. Among our customers are AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Eli Lilly, Glaxo Smith Kline, Novartis, Novo Nordisk, Pfizer, Roche, Bayer-Schering and Merck-Serono.