CC Compounding Sr. Technician 高级配液技术员

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Job Summary职位概述:

The job holder ensures to meet / perform 该职位确保满足/执行
-Team and training 团队和培训
-Leadership and continuous improvement 领导力和持续改进
-Legal, regulatory and business framework 法律，法规和业务框架
-Product availability 生产实现
-Product review 产品审核
-Product issue management 产品问题管理
-Data analysis 数据分析
-Documentation 文件
-Application management/information management 应用软件/信息管理

- Main Tasks & Responsibilities主要工作职责 :

Team & Training: 团队和培训
-Assist compounding engineer/team lead to work out training materials with the reference to SOP, technical and production document
协助配液工程师/经理准备与SOP，技术以及生产文件相关的培训材料。
-Support the team induction, training & qualification and development within the department
支持部门内的入职，培训，上岗认证以及发展活动。

Leadership & CI:
-Be responsible for 5S management and participate in Lean activities in Elecsys compounding work area.
负责配液区域的5S管理，同时参与其他精益生产活动。
-Work and communication with functional teams on contribution and supporting project and teams’ targets achievement.
与职能小组合作和沟通从而为项目和团队目标的实现提供支持。
-Learning and developing him / herself during the project and site operation progress with the support by operation team and team lead.
在运营团队和直线经理的支持下进行自我学习和发展

Legal, regulatory and business framework compliance:
-Ensure alignment with the regulatory specifications, defined guidelines as well as legal specifications of work, safety, industry health & environment
确保符合监管规范，定义的指南以及工作，安全，行业健康和环境的法律规范
-Assures compliance with Roche corporate requirements regarding Quality, SHE, and Records Control requirements for operations functions
确保符合罗氏对于运营有关质量，SHE和以及记录控制的相关公司要求
-Ensure that quality, standards and specifications are respected and adhered to
确保遵守质量，标准和规格

Product Availability:
-Execute daily production following standard procedures. As a shift lead, ensure the production output according to production master plan at the agreed upon time and with the quality levels.
根据标准操作程序执行日常生产。作为领班，确保根据生产主计划进行生产并且符合时间和质量的要求。
-Alignment with cross functional teams to ensure a continuous production
与跨职能团队协调，以确保连续生产
-Execution of Elecsys compounding validation batches and support on euipment validation as a key performer
作为关键执行者，进行Elecsys配液生产流程验证批次的生产，并对设备验证提供支持。
-Be responsible for Hygiene zone clean and disinfection.
负责洁净区的清洁和消毒
-Collaborate with site service and QC to work on environment monitor on including Purified water, Clean stream, Process gas and HVAC & hygiene zone rooms.
与厂务和QC部门合作对生产区域以及相关设备包括纯水系统，洁净蒸汽，氮气，空调以及洁净区进行监控
-Collaborate with engineering staff and site service to work on equipment calibration and PM to maintain the equipment in qualified and validated and complete relevant operation in United D system.
与工程部和厂务合作完成设备的校验和维护，使设备处于验证有效状态。
-Be responsible for consumable/indirect material storage planning and maintenance.
负责耗材/非直接物料库存的计划和维护

Product Review:
-Assist compounding team lead on assessing and managing on product quality (trendy analysis)
协助配液经理评估/管理产品质量 (趋势分析)
-The support to review and assessment of batch document
协助审核生产批记录

Product Issues management:
-Assist compounding engineer/team lead to ensure timely processing of product quality issues, systematic investigation and analysis, support the technical solution and actions as well as documentation.
协助配液工程师/经理及时处理产品质量问题，完成系统调查分析，技术方案和执行以及文件化。

Data Analysis
-Collect and review of specifications and data from the production with compounding engineer.
协助配液工程师收集和复核生产规范和数据

Documentation:
-Assist compounding engineer / team lead to transfer existing DOM (Diagnostics Operations Mannheim) Documentation requirements to fit RDSZ needs and creation of bi-lingual documents and templates
协助配液工程师/经理根据RDSZ的需求对现存的DOM文件进行转移，以及生成中英文双语版本和文件模板。
Applications Management
-Execution of system and process analysis in preparation to IT projects as well as optimization of the existing system landscape
对筹备中的IT项目进行系统和过程分析，以及优化现有系统环境
-The support force of IT systems for the area
提供本区域的IT系统支持
-Assist compounding engineer / team lead work on master data collection / maintenance and final testing in United D system for Manufacturing Module.
协助配液工程师/经理对United D系统中生产模块所需的主数据进行收集/维护，以及参与*终测试。



Education& Qualifications教育背景与专业资格:
-College and vocational school education in Biological Sciences, Pharmacy, Chemical, Mechatronics or related field, or equivalent combination of education and work experience.
大专或技校生物，药学，化学，机电一体化专业，或具有相等教育和工作经历。

Experience工作经验:
-3~4 years experiences in a highly regulated cGMP manufacturing environment
3~4年cGMP生产环境工作经验。
-3+ years’ experiences in IVD or Pharma production
3年以上IVD生产企业或药厂工作经验
-3+ years’ experience with documentation
3年以上文件编写处理经验
-2 or 2+ years’ experiences in SAP system
2年或2年以上SAP操作经验。
-Fresh graduates from university considered
考虑应届大学毕业生

Language skills
Native or fluent Chinese 普通话流利
Good in English reading and writing 英语读写良好

Leadership Competencies领导能力：
Leadership competencies at appropriate level, in line with corporate framework.
参照罗氏集团领导能力标准和要求，领导能力达到相应水平
Professional Competencies/skills专业能力/技能:
-Professional and positive approach with learning agility
专业和积极的方法与学习敏捷性
-Diligent with attention to detail
注重细节
-Effective communicator at all levels and collaborates well
能在各级进行有效沟通，协作能力良好
-Expected to operate independently, holding him/her accountable to proactively fulfill tasks and achieve results within assigned timelines.
可以独立工作，他/她能主动承诺完成任务并在规定的时间内取得成果
-Dynamic and vigorous
-有活力，有热情
-Self-motivated & self-sufficient
自我激励,自立自信
-Team player with the ability to work on their own initiative
团队协作
-A can-do attitude and willingness to go the extra mile when required
-具有 可以做 的态度和愿望，在需要时能承担更多任务。