Process Specialist, Quality (日语和英语)
精鼎医药研究开发(上海)有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-02-27
- 工作地点:沈阳
- 招聘人数:1
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:日语熟练
英语熟练 - 职位月薪:面议
- 职位类别:生物工程/生物制药 其他
职位描述
Interface with PAREXEL business units and corporate functional units to determine process related issues, needs to address operational performance requirements Educate and advise business management on process improvement opportunities through the use of methodology, data and fact Work to satisfy the PAREXEL Quality goals of providing break through and continuous improvement. Employ recognized process improvement methodologies to eliminate waste and rework as well as break through improving business performance Interface with business and functional units to determine analytical tools needed for process analysis and improvement projects Prepare project work and investigate, select, and identify specific tools for projects covering business area or functions, in-order to improve efficiency of project work Assist in the development of methodology and training materials and provide process analysis and mapping training to staff in operational or business units, as required. Work with SMEs in SBUs and CAUs to generate process maps and to create SOP workflows from process maps. Supporting lead authors with Work Instruction (WI) development. Work closely with Controlled Document Specialists to make SOPs and WIs effective in P-MED Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales. Skills Excellent interpersonal skills (English, Chinese, Japanese & preferably Korean) and proven ability to work with all levels of a multinational and multicultural organization as a change agent Excellent computer skills in a Microsoft Windows environment. Must include Excel, Word, PowerPoint and Adobe. High energy self starter; must be able to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team Familiarity with analytics and basic statistics, logic design concepts Familiarity with structured process analysis and improvement methodologies, business process modeling and an understanding of business workflows. Lean Six Sigma skills such as DMAIC, Design for Six Sigma, Lean, Process Management and statistics, SOX, and process simulations are highly desirable Understanding of GCPs, FDA regulations, and current industry trends is preferred Maintain professional awareness by reading and taking an interest in business management activities outside of immediate employment Willing and able to travel as required – local or international. Excellent interpersonal, verbal and written communication skills (English, Chinese, Japanese & preferably Korean) Client focused approach to work A flexible attitude with respect to work assignments and new learning Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork.
*Job Qualifications
Education
Educated to degree level (technology, biological science, pharmacy, business management or operational research or other related discipline preferred) or equivalent qualification or clinical research experience
Bachelor's Degree in business management or operations research with statistical analysis
Ideally, process analysis and mapping with improvement methodology training in an academic environment
Language Skills
Fluent in written and oral English, Chinese, Japenese & preferably Korean
Minimum Work Experience
Experience in process consultancy and/or project management or equivalent role
*Job Qualifications
Education
Educated to degree level (technology, biological science, pharmacy, business management or operational research or other related discipline preferred) or equivalent qualification or clinical research experience
Bachelor's Degree in business management or operations research with statistical analysis
Ideally, process analysis and mapping with improvement methodology training in an academic environment
Language Skills
Fluent in written and oral English, Chinese, Japenese & preferably Korean
Minimum Work Experience
Experience in process consultancy and/or project management or equivalent role
公司介绍
精鼎医药(Parexel International)是全球领先的药物研究合同委托机构(CRO),总部位于美国生物医药圣地马萨诸塞州的波士顿附近,在世界各地拥有71个办事处,约17,600 名员工,为超过100个国家的客户提供服务。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
精鼎医药成立于1982年,在三十多年的历程中,一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商,并且取得了卓越成果。目前,我们能够提供全世界CRO领域全面的新药临床阶段研发服务,服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。
将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案,可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。
联系方式
- Email:tony.feng@parexel.com
- 公司地址:上海市浦东新区商城路506号新梅联合广场B座9层 (邮编:200120)