Formulation Engineer ?

The position

plays an important role in cGEP and cGMP, and continuously improving standards in operation process. Main Job Tasks 主要工作任务: • 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. 撰写工艺和验证相关文件，包括：PSE, VSS, VSR, APR, QMR等 。 • Monitor the process trending. 监控工艺流程趋势。 • Lead and drive process optimization and improvement. 推动工艺优化和改进： • 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 • Participate in validation, technology transfer and process improvement: 参与验证、技术转移和工艺改进 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. Print job Send to e-mail