莆田招聘

? Minim 7 years of relevant working experience. Thereinto minim 5 years of production experience in aseptic process of cGMP regulated pharmaceutical industry or in life science industry. 至少7相关工作经验，其中至少5年cGMP规范药厂或者生命科学行业无菌生产的工作经验。
? Knowledge and experience on cGMP or GMP manufacturing process validation/qualification. cGMP或者GMP生产制造工艺流程验证的知识和工作经验。
? Experience of working in cross function team environment. 在跨职能团队环境中的工作经验。
? Strong documentation experience. 文件处理经验。

Education Background: 教育背景

? Bachelor Degree and above in mechanical engineering, industrial engineering, electrical engineering, chemistry, pharmacy, bioscience, computer science or similar education background. 工业工程、化学、制药、生物以及材料科学或相关学科领域大学本科及以上学历。
? Education/training of cGMP is preferable. 接受过cGMP的培训优先。
? Fluent in written and reading English. 流利的英语听说技能。


Main Job Tasks ：
? 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. Represent Site Tianjin to answer the process related questions of during internal or external audit/inspection. Be the owner of internal or external audit finding. 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。在审计或检查中代表天津工厂回答工艺相关的问题。担任审计发现的改善行动负责人。

? Be the CAPA owner for investigation. Handle critical NCs/ICs/CCs fast with high quality by finding root cause and no comments during audit. 担任纠正和预防活动的负责人。找到根本原因，快速、高质量地处理关键NC/IC/CC，确保审计中没有问题。

? Write critical CR and complete change on time. 撰写关键CR并按时完成。

? Be the owner of process risk assessment. Plan validation and re-validation with shortest stop for production and write high quality validation documentation. 担任工艺风险评估负责人。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。

? Instruct or write process and validation related documents with high quality including QRM, VMP, VMP, PPP, PPR, PSE, VSS, VSR, APR, QMR, etc. 指导或撰写工艺和验证相关文件，包括：QRM, VMP, VMP, PPP, PPR,OPV, VSS, VSR, APR, QMR等 。

? Monitor the process trending and lead or coach investigation for abnormal trending. 监控工艺流程趋势，推动或者培训对非正常趋势的调查。

? Lead global process optimization/improvement project locally and ensure the local implementation of DFP standard. 带领全球工艺改进项目的本地化实施，确保按照DFP统一标准执行。

? Be process responsible of Site Tianjin or back up. 担任天津工厂工艺流程负责人的角色。

? Lead and drive process optimization and improvement. 推动工艺优化和改进：
o Be process responsible or back up to represent STJ for discussing and aligning improvement among DFP sites. Ensure the local implementation of DFP standardization. 作为流程负责人代表天津工厂与其他DFP工厂探讨工艺改进， 确保按照DFP统一标准执行。
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 Drive 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、更好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。

? Train the trainer in production support team. 在生产支持团队的担任内部讲师培训者。

? 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 CAPA investigation. Be the CAPA monitoring responsible to continuously monitor and analysis input sources to identify quality problems. 推动纠正和预防活动研究，持续监控和分析并发现质量问题。
o Drive problem solving/event response to local problems and comprehensive DVs. 推动问题解决和复杂偏差的处理。
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 Be responsible for the local implementation of global standard or procedure. 负责全球标准和程序的本地化执行。
o Be or instruct the owner of local standards. Be responsible for developing and maintaining local procedures and standards within the process, including local JTP’s and training material. 指导本地标准的负责人，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 Coach or 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 Lead product transfer or local implementation of global project. 领导产品转移项目
o Own the process risk assessment and ensure the validation status of process or equipment is maintained based on risk assessment. 负责工艺风险评估，确保流程或者设备验证基于风险评估进行。
o Instruct on or participate in local validation and verification of process, machine and equipment.　　指导实施对工艺流程、机器、设备的核查和验证。
o Be responsible for critical event response and VDV handling during validation.　　　　　　　　　　　　验证过程中处理关键问题和关键验证偏差。
o Review and approve validation document and share best practices with relevant stakeholders. 检查并批准验证文件，分享更好实践方法。
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. 无菌区域行为规范负责人。

诺和诺德在中国
诺和诺德是中国市场的领导者，一直以改变为己任。诺和诺德（中国）制药有限公司于1994年成立，二十几年来业务一直保持强劲增长。公司总部设在北京，产品和服务遍及全国所有省、直辖市及中国港澳台地区。截至2017年底，诺和诺德在华员工总数4329人。诺和诺德是在中国建立研发中心的生物制药公司。位于北京的研发中心是诺和诺德全球研发体系的组成部分，致力于与总部合作研发新产品及新生产工艺。诺和诺德在中国的生产厂位于天津，是公司的国际化战略生产基地。公司对工厂提供了大量的资金投入和技术支持，向全球以及中国市场供应产品。诺和诺德在中国的不断发展反映了公司对中国市场的承诺。

Novo Nordisk in China
As the leader in the Chinese market, Novo Nordisk has always been committed to Changing.
Founded in 1994 and headquartered in Beijing, Novo Nordisk’s presence in China has been growing for more than 20 years.Headquartered in Beijing, providing products and services across mainland China as well as Hong Kong, Macau and Taiwan of China. As of the end of 2017, Novo Nordisk employed over 4,329 employees in China.