EM Professional III

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

• Bachelor Degree and 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。
• 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 :

• Minimum 4-6 years of working experience related to quality or manufacture. 4-6 年质量或者生产制造相关工作经验。
• Previous working experience in GMP regulated pharmaceutical industry is strongly preferred 有制药行业 GMP 相关工作经验最优先。
• 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. 有设备或工艺验证的工作经验优先。
• Previous experience with project management is preferred.  有项目管理的工作经验优先。
• 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。

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 J ob  T asks  主要工作任务 :      

• Develop and maintain standards, processes and procedures of environment monitoring in accordance with requirement, including:                                                                                      依据相关要求建立并维护环境监测标准、程序和工作流程，包括：
  • Cleaning  清洁
  • Sampling  采样
  • Gowning, behaviour, hygiene for aseptic production areas and CNC areas                           无菌生产区域工作服着装、行为、职业健康
  • Material flow   材料流动
• Perform aseptic area qualification by:                                                                        执行无菌区域资格认定工作：
  • Plan and drive qualification activities and coordinate execution with production departments. 计划并推动无菌区域资格认定工作相关活动，与生产部门协调行动计划的执行。
  • Prepare protocols, test plans and reports. 准备资格认定书，测试计划以及测试报告。
  • Investigate validation non-conformities, determine root causes, and design and implement corrective and preventative actions. 调查验证发现的偏差，找到根本原因，制定并执行纠正、预防行动计划。
• 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：
  • Evaluate, select and purchase equipment. 评估、筛选和购买设备
  • Develop and implement relevant SOPs for operating and maintaining equipment. 建立和执行设备操作和维护相关的标准操作流程
  • Prepare and review logbooks. 准备并检查日志
  • Perform qualification, calibration, and maintenance activities. 执行设备校验、验证、维护等活动
  • Follow up equipment running status. Fill in follow up forms, handle EM relevant equipment problems. 跟踪设备运行  状况，记录跟踪表，处理设备问题。
  • Train equipment end users. 培训设备最终用户
• 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：
  • Write CR, NC and close on time. 处理变更、偏差事件，按时完成相关行动和文件。
  • Be well prepared for audit in order to obtain the high rating in NN internal audit and pass all inspection from external authorities. 针对审计和检查做好准备和应对，以顺利通过内、外部检查。
  • Train all related employees with new improvement procedure. 当有新的改进程序时，及时培训相关人员。
  • Develop and review CR cases for relevant changes including update of global DFP standards, coordination of CR cases, giving feedback on the status of ideas/input to the originator of idea. 当有变动发生时，审核内容并及时给予意见和反馈。
  • Ensure anchoring of process improvement projects in local site project portfolio. 参与执行流程改进项目。
• Ensure daily support production units within the EM process area, including: 支持日常生产活动：
  • Ensure that efficient process KPIs are defined and followed up upon. 定义有效的流程绩效指标并跟踪执行情况。
  • Review routine EM parameter, analysis the data and generate reports. 日常检查环境监测参数，分析数据，做分析报告。
  • Prepare batch release report for EM data to support product release. 准备产品批次放行环境监测数据。
  • Ensure that SOP’s and standards within the process are effective by evaluating how they are used and work in praxis. 通过做过程确认确保 SOP  和标准被有效执行。
  • Ensure compliance to external and internal regulations. 确保日常生产活动合规。
  • Responsible for presenting process under inspection and audit. 在审计和检查时介绍 EM 相关工作流程。
  • Involve into VHP process including sign contract, material preparation, training and coordination to each department participate VHP process as well as VHP protocol, report, etc. 参与 VHP 工作