职位描述

职位描述： Position Overview - This is an individual contributor position that requires an individual with knowledge/experience utilizing document management systems and processes in Medical Device/pharma/Biotech industry. The individual in this role will be responsible for leading the effort to coordinate documentation transfer for new China manufacturing facility from US, work with cross functional team. This position is based in shanghai and report to the site QA manager. Responsibilities - In this role the individual will be responsible for coordinating shanghai site document management activities. - Specific responsibilities include: - Support QMS documents transfer and implementation from US to China. - Establish the sub-system for the document and record management process for new China site. - Coordinate with other project/site functions, e.g., Manufacturing, Technical Operations, Engineering, etc. to transfer. review, update and implement all departmental documents in China . - Manage and maintain electronic documentation management system . - Manage all document change requests for the new manufacturing site in China. - Communicate changes that have impacts to product design, quality, safety and manufacturing processes to both US and China Change Review Boards - Manage and monitor all external file, include Global procedures/standards, Chinese IVD and general international regulation for medical device. Required Knowledge/Skills, Education, and Experience Experience: - A minimum of 3 years in Medical Device/Pharma/Biotech industry with at least 2 years in a role working in Document Control or Document Management. Education: - A minimum of a 4 year degree is preferred, although a combination of education/experience will be considered. Skills/Knowledge/Experience: - Prior experience working in a CFDA, ISO13485 regulated environment. - Good English verbal and written communication skills. - Prior experience with document management software, e.g., SAP, Documentum, Agile, etc. - Must be able to work collaboratively with other project team members. Preferred Knowledge/Skills, Education, and Experience - Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.提醒： 　　点击“西门子专属申请”，您将会进入西门子专属招聘系统，进入系统后您可以在页面右上方的下拉菜单，选择简体中文页面，并请遵循下面的规则设置您的系统密码。 　　密码设置规则：密码长度必须在8个字符以上，并且必须包含英文大写字母，小写字母和数字。例如：Ab123456 职能类别： 药品生产/质量管理 行政专员/助理

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