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10年以上经验 -
招1人 -
英语熟练 -
11-09 发布
职位描述
职位描述： 1.Define and review validation , qualification and GMP complains related regulations , code and standards ( CFDA and international GMP shall be considered )2.Develop and update project Validation Master Plan3.Review and update project GMP Risk Assessment4.Lead the qualification team to develop qualification plan for process , clean room / HVAC, critical utilities and EMS system5.Coordinate with design team for DQ review and design GMP upgrade6.Drive the qualification team to develop, review and update GMP Risk Assessment , system impact assessment for the project7.Drive the project qualification team to develop/ review URS , DQ, IQ , OP , PQ protocol for process , clean room / HVAC and critical utilities’ system8.Lead the project qualification team , vendor and client operation team to execute DQ, IQ , OQ and PQ for clean room / HVAC , EMS critical utilities system9.Lead project qualification team , vendor and client process team to execute DQ,IQ, OQ and support PQ execution for process system10.Provide qualification summary and validation summary report11.Support client to perform the key interface with local CFDA to ensure the schedule and quality of project qualification documentation submission and support client to obtain GMP license. 职能类别： 生物工程/生物制药
联系方式
总部地址：上海闸北区恒丰路436号环智国际大厦10楼
公司信息
美施威尔集团是一家跨国的工程公司，在行业中占主导地位。它为在微电子、平面技术、光伏、生物制药及新能源等高科技领域的全球知名的企业提供复杂的工程及设备方案。美施威尔集团的总部位于德国斯图加特市。在全球范围内拥有40多家子公司，主要分布于美国区、欧洲区及亚太区，有8100多名正式雇员。 美施威尔（上海）有限公司作为美施威尔集团在亚太区的独资子公司，在中国成立于1994年。拥有机电总包一级资质及建筑总包二级资质。主要经营范围是在微电子、平面技术、光伏、生物制药及新能源等高科技领域提供全方位的咨询、设计、施工和运营服务。美施威尔(上海)有限公司以信誉、文化多元化、以员工为骄傲、以人与环境为本、以客户为导向以及信任作为其秉承的核心价值观。 随着十九年在中国的持续快速发展，正式雇员已经发展至500多名。为今后更快的发展及成功，我们诚邀下列人才加入我们的团队。公司将提供具有竞争力的薪资待遇及良好的职业规划。 M+W Group is the global engineering company on the leading position to provide the comprehensive solution of facility engineering and high-tech manufacturing facilities for the clients in the industries of semiconductor, flat panel, photovotac, life science and nutrition, new energy etc. The head quarter of M+W group is located at Stuttgart, Germany. In worldwide it owns around 40 subsidiaries, divided into three business unit, including America Unit, Europe Unit and Asia Pacific Unit, and with more than 8100 employees. M+W (Shanghai) Co., Ltd is the wholly foreign owned subsidiary of M+W Group in Asia Pacific which was established by 1994 in China. It possessed general contractor CQC license of Grade A for ME and Grade B for building. The business scope of M+W Shanghai is to provide the engineering and construction service in whole China in the industries of semiconductor, flat panel, photovotac, life science and nutrition, new energy etc. The core value of M+W Group includes Credibility, Cultural Diversity, Pride in our Employees, People and Environment, Customer Orientation and Trust. With 19 years continuous fast growing in China, M+W Shanghai is with more than 500 employees. For further growth and success, we sincerely invite the following talents to join our team. We will offer good career and competitive remuneration package for the successful applicants.
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