- SRV/Science- and Risk-based validation 验证相关工作
- Maintenance the compliance between authority and NN requirement, also between the global standard and local SOPs. 基于内/外部规则和总部/本地标准的要求,维护生产的合规性。
- Well prepare for audit in order to obtain high rating in NN internal audit and pass all inspection from authorities. Be the owner of audit/inspection finding action. 充分准备审计以通过NN内部审计和外部检查并取得优异结果。担任审计发现的改善行动负责人。 Handle NCs/ICs/CCs fast with high quality by finding root cause and no comments during audit. 找到根本原因,快速、高质量地处理NC/IC/CC,确保审计中没有问题。
- Write CR and complete change on time. 撰写CR并按时完成。
- Plan validation and re-validation with shortest stop for production and write high quality validation documentation. 在保证最短停产时间的前提下计划验证和再验证,撰写验证文件。
- Write process and validation related documents with high quality, including PSE, VSS, VSR, APR, QMR, etc
- Monitor the process trending. 监控工艺流程趋势。
- Lead and drive process optimization and improvement
- Train the trainer in production support team. 培训生产支持团队的内部讲师。
- Ensure daily support and sparring to production units and support units within the process area including: 确保对日常生产的工艺支持: o Ensure that efficient process KPIs are defined and followed up upon. 制定高效的工艺关键绩效指标并跟踪执行。 o Drive problem solving/event response to local problems and comprehensive NCs. 推动问题解决和复杂NC的处理。 o Identify improvement opportunities and implement locally with documented benefit and drive local improvement projects. 寻找改进点并实施改进,推进改进项目执行。 o Own local standards. Be responsible for developing and maintaining local procedures and standards within the process, including local JTP's and training material. 负责开发和维护本地工艺流程标准,包括准备培训材料和培训计划。 o When standards are changed ensure that relevant training documents are updated and initiate training of relevant employees by informing LoB about new standard. 当有标准变化时,及时通知相关业务部门,更新培训文件并对相关员工实施培训。 o Ensure SOPs and standards within the process are effective by evaluating how they are used and work in praxis through PC. 通过进行过程确认确保工艺相关SOP和标被准有效地执行。 o Ensure compliance to external and internal regulations. 确保合规 o Responsible for presenting process during inspection and audit. 在审计和检查时介绍工艺流程。 o Be 'on point of entry' to the process regarding solution. 作为工艺解决方案的唯一接口人。
- Participate in validation, technology transfer and process improvement: 参与验证、技术转移和工艺改进: o Ensure the validation and verification of process, machine and equipment. 确保实施对工艺流程、机器、设备的核查和验证。 o Be responsible for event response and NC handling during validation. 验证过程中处理问题和NC。 o Review and approve validation document and share best practices with relevant stakeholders. 检查并批准验证文件,分享最佳实践方法。 o Escalate problems according to escalate procedure. 按照程序上报问题。 o Be aseptic behaviour owner in process department by leading smoke study.
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Isolator filling Engineer - Bagsværd, Danmark - Novo Nordisk A/S - Nn1
Beskrivelse
The position plays an important role in cGEP and cGMP, and continuously improving standards in operation processMain Job Tasks 主要工作任务:
撰写工艺和验证相关文件,包括:
PSE, VSS, VSR, APR, QMR等 。
推动工艺优化和改进:
o Lead and coach improvement activities, improvement of standards within assigned process. 指导和训练改进活动和工艺流程标准的改进。 o Participate in event response activities using SPS method, establishing cause and effect relationships that determine root causes. Leverage solution, best practices and benefits to process group through business case. 运用系统解决问题的方法处理事件,确定根本原因,通过事件处理案例平衡解决方案、最佳实践方法以及对工艺部门的益处。 o Ensure anchoring of process improvement projects. 实施工艺改进项目。 o Be responsible for ensuring that local standards are translated in accordance with DFP standard. 负责确保DFP标准转化到本地标准。
You have a technical background, preferably academic, within one of the following fields of study: chemical engineering, electrical engineering, mechanical engineering, biotechnology, or chemistry.
You are a skilled communicator and are comfortable to have English as your main working language. Mastery of the local site language is a huge advantage.You have an international mindset and can succeed in a global- and complex stakeholder landscape, moreover, you find it motivating to travel a lot as part of your job.
You have a proactive mindset and can work independently in a project environment, which sometimes is characterized by limited clarity and structure.
You preferably have experience from the world of aseptic production. 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.
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