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QC LabEX Project User team Subject Matter Expert

 
岗位信息
  • 更新时间:2020-03-21
  • 学历:本科
  • 工作地点:上海市
  • 语言要求:
  • 工作年限:不限
  • 招聘人数:若干
  • 月薪:0-1000元
  • 性质:其它
岗位要求
3. Principle Roles & Responsibilities / Accountabilities 主要职责/责任
(Major functions of the position) (职位的首要职能)

The qualified candidate will work effectively in QC LabEX project teams;
合格的候选者必须能够在QC实验室扩展项目团队中有效的工作;

This position will focus on the managing qualification activities on the QC LabEX project. The Subject Matter Expert will be responsible for:
这个职位主要负责管理项目中的审核事宜,这个职务必须对以下事宜负责

? Responsible for project user requirements and all user related deliverables assigned by UTL
负责完成由用户团队负责人布置的、项目用户的需求和所有用户相关的任务

? As the SME of user team members through the resolution of user/project related issues.
作为用户团队的专家,解决用户/项目相关的问题

? Support UTL to establish the business case, as the requestor of user generated change orders.
协助用户团队负责人表明业务需求,作为用户请求生成的变更的发起者

? Responsible for co-draft and review critical design deliverables during the PI, CD, BD, DD and Commissioning phases of the project, including qualification documents, computer system validation documents, and other project related GMP or non-GMP documents.
负责在项目的PI、CD、BD、DD、Commissioning阶段,参与起草和复核关键设计任务,包括确认的文件,计算机系统验证文件,和其他项目相关的GMP或者非GMP的文件。

? Provides information on process requirements and coordinates quality and operational impacts.
提供流程的需求,协调质量和操作的影响

? Responsible for the documentation and implementation of transition the project from hand-over to Performance Qualification (PQ), Operational start-up, and facility operation.
负责项目的移交,包括性能确认(PQ),运行启动,以及设备运行的文件准备和执行

? Support the coordination between UT and Roche project team, vendor, and/or contract outsourcing supplier.
支持用户团队与Roche项目组、供应商或者外包的资源合作和协调


1.Qualification and Experience 能力与经验

Education/Qualifications教育程度/所获资格证书
B.S. of Science Degree or equivalent with 5 or more years GMP lab or related technology experience in pharmaceutical industry.
拥有理学士学位或同等学历,在医药行业GMP实验室或者相关领域拥有5年或5年以上工作经历。

Experience in instrument qualification and other analysis in pharmaceutical GMP lab is preferred.
优先考虑具有在GMP实验室有设备确认或者其他分析相关经历的人。

Leadership Competencies领导者胜任力
?Focus on creating value by customer at the center of what we do 以客户为中心的价值导向
?Mobilize the organization by building trustful and effective relationships 建立信赖且高效的组织能动性
?Deliver results by taking responsibility, driving results, and achieving expected outcomes 勇担职责、结果导向并达到期望
?Innovate by actively seeking learning 主动学习引导创新

Champions self-initiated or assigned projects. Justifies project goals to colleagues. Acts as a mentor for those with similar or less engineering expertise.
对于自发的和布置的项目有必胜的决心。为同事解释项目目标。为拥有相近或较差工程经历的同事起到表率作用。

Contributions are integral to the success of both technical and organizational objectives.
对于技术和组织上的目标的成功达成同时做出贡献。

Strong technical leadership, collaboration, and sound business value based prioritization and problem solving skills.
有很强的科技领导能力,协作能力,商业判断力和解决问题的能力

Job Required Competencies岗位所需胜任力

Professional knowledge of quality control process in a cGMP environment.
拥有在cGMP环境中的质量监控流程的相关专业知识

Knowledge in data analysis and presentation.
具有数据处理和有效汇报的知识。

Knowledge in change control, could initiate change control and follow up the change control process individually.
具有变更控制的知识,可以独立发起和跟进变更控制流程。

Experience in Quality risk management or similar experience.
拥有质量风险管理相关或类似的经验。

Solid experience and knowledge with lab set-up and instrument qualification is essential.
必须在实验室建设和设备确认方面拥有很强的经历和知识。

Must have excellent organizational, communication, personal work management and writing skills.
必须具备出色的组织,沟通,个人工作管理及写作能力。

With minimal supervision, is expected to make presentations and updates project progress, budget and schedule to UTL.
能在最小的指导下,为用户团队负责人做介绍并且及时更新相关情况、项目的进展,预算和时间表。

Language skills语言技能: :
Skilled in reading professional materials/能熟练地阅读专业资料
Good listening, speaking and writing English ability/英语听说和写作能力佳
Chinese, English on negotiation level.

Computer skills计算机技能:
Familiar with computerized systems /熟悉计算机化系统
Skilled in using Office software, Ex. Word, Excel, PPT, Project/熟练使用Office软件,如Word、Excel、PPT, Project
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