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Production Coordinator

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Location: Suzhou, China
Position Type: Fixed-Term

岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

生产协调员直接汇报给生产经理,是生产部门的技术代表,也是主管现场管理的重要支持力量。生产协调员负责生产部门的安全、质量和生产三个维度的支持。
Production Coordinator reports to Production Manager, he/she serves the production and warehouse team with his/her operational expertise, and he/she is the critical support toward shop floor supervision. This role will support team through three dimensions - safety, quality and production.

 

主要职责 / MAIN ACCOUNTABILITIES

1) 自身安全要求 Safety:
?确保日常工作严格遵守HSE的政策和程序;
Ensure strict compliance with established HSE policies/procedures within daily operations.

2) 自身质量要求 Quality:
?确保严格遵守QA/生产的程序、批记录和要求,确保完成角色所需的必须培训,如更衣、工业化SOP、工程SOP和质量SOP等;
Ensure strict compliance with established Production/QA procedures, ticket and requirements. Ensure individual are trained appropriately with procedures, such as gowning, Indus SOP, ENG SOP and Quality SOP etc.
?确保自己始终遵循良好的文件书写习惯,起好模范带头作用;
Assure that Good Documentation Practices are always followed.
?及时汇报所发现的质量问题,根据质量调查承接相应改善任务。
Report quality observation timely and take ownership on correction and CAPA according to investigation for responsible area.

3) 生产协调 Production Coordination:

安全协调:
Safety Coordination
?作为生产部的HSE专家参与HSE例行会议并协调支持部分安全项目,监控部门HSE指标,对现场的不安全状态做出响应和改善;
Join HSE routine meeting as department level SME and support to coordinate some of safety programs, monitor team HSE matrix, response and improve shop floor unsafe conditions.
?参与现场巡检,监管现场操作层级的安全,确保主管和员工对自己团队和自身的安全负责,指出操作员、翻班QA、技术员、工程师和外部包商工作中潜在影响到现场安全的问题或者汇报给主管及HSE;
Monitor floor execution level safety, be responsible for routine operational safety, raise safety concerns to operator, shift QA, technician, engineer and external vendor from their daily work which may impact floor safety to HSE and/or supervision
?执行部门层级HSE例行培训,负责生产部门层级的安全项目协调;
Execute department level HSE routine instructor-led training and Be responsible for safety project coordination on department level.

质量协调:
Quality Coordination
?作为生产部技术专家参与或领导质量事故调查,包括外部投诉生产端调查、内部部门层级质量事故,相应原因分析和CAPA;
Participate or lead quality investigation as production SME, including external complaint investigation from production perspective and internal department level quality event, cause factor investigation and CAPA identification.
?部门内部质量文件建设和质量指标达成,作为部门内部讲师进行质量意识提升话题的宣讲及推动部门成员达成第一次就做对的质量指标的达成;
Team internal quality culture promotion and pushing quality goal achieving, own the internal communication on quality awareness improvement and pushing team to achieve right the first time goal.
?执行部门内所有变更控制,并维护大部分部门层级SOP,确保他们能反应正确的执行和操作;
Own all change controls in production and warehouse team. Maintain most of department level SOP to ensure good practice can be reflected.
?负责部门人员培训协调工作,监督并可视化人员培训完成状况;
Coordinate department staffing training status, monitor and visualize training completion status.

生产协调:
Production Coordination

?收集并监控生产绩效指标,协调生产资源完成工时数据、CPV等数据收集,用于分析指导后续改善;
Collect and Closely monitor production and warehouse performance indicators, coordinate production resource to complete data collection on production cycle time, CPV and etc to guide upcoming improvement accordingly.

?定期执行现场巡检,支持现场5S管理,确保生产和仓库现场一直处于审计待命状态;
Execute floor gemba walkthrough, support shop floor 5S management, ensure production and warehouse is in an inspection readiness status.

?给予现场人员人为出错减少建议,优化工艺设计和设备操作方式;
Provide suggestion to reduce floor human error, improve process and practice.

?统计收集生产现场和仓库的持续改进和精益点子,协助现场实现选定方案;
Summarize and collect Continuous Improvement and Lean ideas, facilitate team to realize selected ones.

?在一线展示技术领导力,在必要的情况下候补生产主管,比如主管休假。
Demonstrate technical leadership on shop floor, if necessary, backup production supervisors in a short term period, such as supervisor is not available.

?向生产/仓库主管根据设置好的部门目标和检查到的问题提供操作员绩效反馈并给予评分建议,及时向主管反馈人员保留风险,为有效人员保留提供人员发展推荐;
Provide operators’ performance feedback and ranking suggestion according to pre-defined matrix and recorded observations. Provide alert on people retention risk to supervisor, and recommend personnel development solution to retain people.


知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

?具有三年以上制药或医疗器械工厂相关经验,熟悉GMP和ISO13485;
More than 3 years Pharmaceutical or IVD Manufacturing Experience, be familiar with GMP/ISO13485.
?很强的执行力和推进力;
Strong execution and propulsion.
?极强的人际交往能力和领导力才能来进行跨部门和操作员的沟通;
Strong interpersonal skill and leadership to communicate with cross-functional team and operators.
?能接受灵活工作时间/翻班/加班;
Enable to accept flexible working time, work on shift and work with proper overtime.
?熟悉电脑操作系统,善于使用MS Office,有MES, SAP, Trackwise, Traksys等使用经验为佳;
Be familiar with windows OS, master MS Office, MES/SAP/Trackwise/Traksys are plus.
?无职业病及色盲。
No occupational disease and color blindness.

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