Quality Engineer (职位编号：010) 上海

月薪：

该公司所有职位
  • 5-7年经验
  • 本科
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 通讯补贴
  • 专业培训
  • 定期体检

职位描述

职位描述： Job Description:The Quality & Validation Assurance department at NNE China is looking for an energetic and enthusiastic person to join our team of Quality Engineers in our Shanghai office. As a Quality Engineer with NNE you will be working with a range of quality issues in our capital investments projects within the pharmaceutical and biotechnology industry. Your main responsibility is to assure that the projects are executed efficiently and all customer and health authorities’ requirements are fulfilled.?Communication and coordinating with customer at site to execute the calibration of critical instrument and validation activity according the NNE procedure.?Prepare the qualification documents e.g. risk assessment, protocols, executing qualification and testing, in accordance with NNE procedures?Maintains proper documentation of all validation activities in accordance with approved procedures. Responsible for investigation and assessment of all kinds of deviation, which found in validation activity. Write validation activity summary report.?Familiar with clean utilities, cleanroom and process equipment qualification. Aseptic filling or OSD process experience is preferred?Provides technical expertise and training to customers.?Organize project GMP risk analysis?Preparing audit documentsQualification:You have the following background:?National and international GMP knowledge.?Validation experience.?ISO 9001:2000 knowledge.?Experienced in GMP, FDA and ISO quality systems.?Minimum a Bachelor’s degree in the relevant field.?Minimum 5 years related work experience in pharmaceutical or biotechnology industry.?Fluent in English – both oral and written.Other Requirements:?Accountable for results with proactive attitude?Creative, self-motivated, actively participate in specific initiatives and promote positive company culture?Open-minded and ready for change?Willing to travel?Cooperate and collaborate with business partners with good teamwork spirit?Customer focus, understand and satisfy internal and external customers?Continuously improve?Good communication, negotiation and interpersonal skills in English and Chinese?Detail-oriented with good planning and organizing skill in regards to the task?Provide high quality solution for customer and work in an efficient and timely manner 职能类别： 生物工程/生物制药

联系方式

新华路660号405室

公司信息

恩宜工程有限公司在医药生物工程领域是世界上最领先的工程咨询公司。我们的业务涵盖生物制药，疫苗及医疗器械，帮助客户开发、建立和改进他们的生产。恩宜珐玛在全球超过25个地方拥有将近1600名员工。“Engineering for a healthier world” 是我们的使命。我们致力于改善全人类生活的事业。恩宜珐玛在1995年进入中国，总部位于天津，分公司分布在上海和广州。在中国，恩宜珐玛拥有400名员工，涵盖所有工程专业，为客户提供全面的工程服务。我们对整个供应链有独到的见解，以广为认可的项目执行模式，15年来为国内客户提供一流工程服务，服务范围包括，咨询，前期调研，工程，项目和施工管理到试运行和验证，以及全套的自动化解决方案，洁净室和模块化设施等。

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企业入驻日期： 2017-11-09

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