Production Support

Category:  Manufacturing
Location: 

Tianjin, Tianjin, CN

   

诺和诺德(中国)制药有限公司天津生产厂是诺和诺德全球唯一的胰岛素耐用注射器械供应商,以及重要的胰岛素制剂与灌装生产基地,在2019年和2020年连续两年荣获Kincentric“最佳雇主称号。

 

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

 

  • Bachelor degree major in engineering or similar field.                                             工程专业背景或相关学科领域大学本科毕业。
  • Computer skill of MS office                         计算机办公软件操作技能。
  • Basic English skill.                                 具备基本英语技能。

    Professional Experience专业经验:

     

  • 1-3 years of production experience in pharmaceutical industry with cGMP regulated aseptic process or in life science industry.                                       具有一至三年在有cGMP要求的无菌生产流程的药厂或者生命科学行业企业的工作经验。
  • Experienced in standardizing work.                        具备标准化工作的经验。
  • Knowledge of cGMP is preferable.                        最好具备cGMP的知识。

Job content工作内容描述

Key areas of responsibility 主要工作职责:

Production support is responsible for supporting AP production from the following aspects:                          生产支持的职责是从以下几方面支持AP生产

  • Prepare BPR and system for rash orders to ensure production delivery and release lead time.                 做好批生产记录文件和系统的准备以支持快速紧张的生产订单计划,确保及时交货。
  • Set up and maintain training system to operation team and has impact on training effectiveness.             建立并维护针对生产人员的培训系统,对培训效果负责。
  • Prepare audit documentation based on SME requirements to ensure high performance during audit.          按照过程专家的要求准备审计文件,以保证取得优异的审计结果。
  • Responsible for QMS documents handling, including: Deviation (DV), Customer Complain (CC), Change Request (CR) e.g.                                                                                           负责处理一些QMS文件,包括偏差,客户投诉,变更申请等。

Support production by providing the fast reaction for the quality issues.                                      迅速响应生产中的质量问题。

Main Job Tasks 主要工作任务:      

  • Conduct batch document related tasks.                                                                     执行批生产记录文件相关任务:
    • Prepare, review and archive the batch document.                                                  准备、检查、存档批记录文件。
    • Train production employees about GDP of batch documentation.                                    向生产员工提供批记录文件操作、使用以及管理的相关培训。
    • Responsible for DI evaluation and training of DI cases.                                             负责数据完整性评估并提供相关培训。        

                              

  • Act as documental and operational trainer for production.                                                   向生产操作人员提供文件和操作的相关培训:
    • Establish and improve training flow and system.                                                   建立并改进培训体系。
    • Standardize and maintain the standard training materials.                                          建立并维护标准化的培训材料。
    • Implement training for operation area.                                                             向生产操作人员提供培训。
    • Conduct training effectiveness check in production.                                                 检查生产培训的有效性。

 

  • Coordinate audit preparation and ensure document preparation.                                             协调相关部门为审计做好准备;保证审计文件准备就绪。
  • Support on data platform collection.                                                                         协助生产数据收集:
    • Collect production data from different systems (logbook, batch documentation etc.)                从不同的系统(日志、批记录等)收集生产数据。
    • Analysis data on right first time and provide action proposal whenever is needed.                   分析数据并提出行动建议,做到一次正确。
    • Do data collection and report on daily board KPI’s.                                                 更新KPI看板上的生产数据。
  •  

    Handle QMS documents including: Deviation (DV), Customer Complain (CC), Change Request (CR) e.g.      负责处理一些QMS文件,包括偏差,客户投诉,变更申请等。

    Other individual assignments 其他工作任务:

  • Incorporate Novo Nordisk Way (NNW) into daily way of working                                              将诺和诺德之道(NNW)融入到日常工作中
  • Other work assigned by line manager.                                                                        直线经理安排的其他工作。
  • Keep line manager accurately informed of work status as well as any problems                               保证将工作状态和所有问题准确通知到直线经理

诺和诺德志在成为世界上最卓越的公司之一。我们坚信,怀抱不同观点、来自不同文化背景的人才相聚于此,是成就卓越企业的关键。因此,我们致力于倡导包容性,让我们的员工、我们服务的患者以及我们置身的社区能够充分拥抱多样性。我们承诺在招聘流程中确保包容性,并为所有求职者提供平等的职业机会。同时,我们热衷于根据不同工作职责和业务需求来探索灵活工作的模式。 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.