Sr.lead MSAT engineer-Technical Transfer

China, Jiangsu, Suzhou

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Job Descriptions:
-    Drive process of new product transfer feasibility.
    主导,推动新产品转移可行性分析
- In partnership with relevant teams to work on feasibility study to define technical transfer requirements including equipment, manufacturability, regulatory, material readiness, shelf life simulation, Q&V, etc.
    与相关部门合作完成新产品转产导入的可行性分析,包括定义产品技术需求,分析设备,生产,法规,物料,有效期,验证策略等可行性

- Act as a technical transfer subject matter experts; collect marketing, customer insights together with technical experts’ opinion to strengthen the Process of product transfer feasibility.
     作为产品转移专家,收集市场以及客户反馈,协同各技术相关部门加强产品导入可行性分析的流程,推动相关问题解决。
- Support technical transfer committee topics where relevant with validation concept, regulatory strategy changes impact analysis, manufacturability, across site product changes, etc.
  推动产品转移委员会上讨论的问题解决,例如验证策略,法规变更对产品转移的影响分析,转产验证过程中的问题解决,涉及多个工厂的产品变更等.

-    Support process of RDSZ product portfolio mgt.
支持产品管理流程
-    Enables decisions on product portfolio based on manufacturability, raw material quality, on market issues and strategic considerations (e.g. plans for out phasing of products).
基于可制造性、原材料、市场问题和战略考虑(如产品淘汰计划),做出产品组合方案,支持决策.
-    Support the RDSZ Technical Transfer process.
支持产品转移流程
-    Drive technical transfer committee topics, problem solving where relevant with validation concept, manufacturability, across site product changes, etc.
推动产品转移委员会上讨论的问题解决,例如验证策略,法规变更对产品转移的影响分析,转产验证过程中的问题解决,涉及多个工厂的产品变更等.
-    Owns Technical Transfer feasibility study documentation and is responsible to defend them during audits and inspections
负责可行性分析相关文件管控,支持各类审核.

Job Requirements:

- Bachelor’s Degree and above in Pharmaceutical Engineering or Chemistry or Biochemistry Science, or business admin

学士学位-制药工程、化学或生物化学,或者工商管理类

- 8 years+ relevant  health industry working experience

8年以上健康产业相关工作经验

- Related work experience in the Diagnostics, Pharmaceutical Industry with the field of technical support, QC and R&D related 

诊断制药行业技术支持,质量控制或研发,产品转移项目相关工作经验

- Solid understanding of the QC/QM/Regulatory process

充分理解质量控制/质量管理/法规流程

- Professional and positive approach

专业和积极的行为思维方式

- Diligent with attention to detail

注重细节

- Ability to cope with ambiguity and pressure

能够应对不确定性和压力

- Collaborates well, while also is capable of dealing with conflict resolution

良好的合作,同时能够解决冲突

- Self-motivated & self-sufficient

自我激励&自我充实

Roche is an equal opportunity employer.

Manufacturing, Manufacturing > Operational Excellence