- Bachelor Degree or above, major in bioengineering, pharmacy, microbiology, chemistry or other relevant field. 生物工程、制药、微生物、化学或相关学科大学本科或以上学历。
- Minimum 3-5 years of working experience related to quality or manufacture.
- Previous working experience in GMP regulated pharmaceutical industry is strongly preferred.
- Previous working experience in an aseptic production environment e.g. pharmaceutical or food industry is preferred. 有无菌生产环境的工作经验优先,如制药、食品行业。
- Previous experience with equipment and process validation is preferred.
- Previous experience with project management is preferred.
- Previous experience of using LEAN/cLEAN principles/tools is preferred. 具有精益生产相关的知识和经验优先。
- SRV/Science- and Risk-based validation 验证相关工作
- 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,PSE, VSS, VSR, APR, QMR 等
- Develop and maintain standards, processes and procedures of environment monitoring in accordance with requirement 依据相关要求建立并维护环境监测标准、程序和工作流程
- Perform aseptic area qualification 执行无菌区域资格认定工作
- Train employees who are in EM, production and all relevant supporting teams for all processes and procedures within environment monitoring field. 培训环境监测、生产以及所有相关支持部门的员工环境监测相关的流程和标准。
- Take the responsibility to ensure EM equipment are working well for daily production 确保环境监测设备运行稳定以支持日常生产
- Handle FMS alarm. Investigate and determine root causes and potential quality impact for FMS alarms related to aseptic production area. Design and implement corrective and preventative actions for alarm occurrences. 处理环境监控系统报警,调查问题,找到影响无菌生产区域的根本原因和潜在的质量风险。设计并执行针对报警发生的预防和纠正行动计划。
- Drive process improvement on EM process. 推动环境监测流程的持续改进
- Ensure daily support production units within the EM process area 支持日常生产活动
EM professional III - Tianjin, 中国 - Novo Nordisk A/S
描述
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,2020年及2022年荣获Kincentric"最佳雇主"称号。
Education Background : 教育背景
Fluent in reading, written and spoken English. 流利的英语听说读写技能。
Professional E xperience 专业经验 :
至少 3-5 年质量或者生产制造相关工作经验。
有制药行业 GMP 相关工作经验最优先。
有设备或工艺验证的工作经验优先。
有项目管理的工作经验优先。
Key areas of responsibility 主要工作职责 :
Environment Monitoring Professional is responsible for ensuring aseptic production environment is qualified and compliance with GMP and all relevant regulatory. Develop, implement and maintain processes and procedures for cleaning and sampling. Prepare for audit readiness and execution, EM qualification and EM excursion investigation and solve problems. The position plays an important role in continuously improving standards in aseptic environment monitoring process. 环境监控专员负责确保无菌生产环境符合 GMP 以及所有相关要求。开发、执行和维护清洁采样的流程;准备好迎接审计;环境资质认定;调查和解决问题。该职位是持续改进无菌环境监控流程标准的重要角色。
Main Job Tasks 主要工作任务 :
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.
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