职位描述
Responsibilities/工作职责:
• Compliance (EHS/GMP/CUSTOMS)/(EHS/GMP/关务)合规:
Strictly follow regulation\SOP requirements, execute the operations with GMP common sense, fulfil Data Integrity requirements every time, all the time.
严格遵守法规、程序的要求,同时按照GMP常识进行操作,时时刻刻满足数据完整性的要求。
Point out the activities or issues which is not compliance, report to manager in timely manner.
及时指出任何违反合规性的操作和事件,并及时向上级经理汇报。
Carry out GMP factory related EHS and GMP rules, to ensure safe operation and safe environment.
贯彻执行工厂相关EHS和GMP安全规定,确保安全作业,维护现场的安全氛围;
Recognize and report the unsafety issue & behavior, and support the investigation which inclueds Nearmiss.
及时汇报不安全因素及不安全行为,并积极参与不安全事件(包括未遂事件)的调查;
Recognize and report the non-compliance GMP issue & behavior, and support the investigation which inclueds deviations.
及时汇报不符合质量规范的行为或因素(包括偏差),并积极参与调查和分析;
Based related dispensing SOPs, execute the routine operation plan, and make sure all the schedule completed on time in full.
遵循称量相关的标准操作规程,执行日常称量生产计划,确保生产计划按时进行;
Based dispensing clean SOP, execute and complete the dispensing equipment disinfection & cleaning.
依据称量设备清洁要求,执行并完成称量设备的清洁和消毒;
According to SOP to complete material related operation in the production aera,such as material handling/cleaning,storing,material transfer/withdrawing,waste management etc., Record timely of the operation process and system data input and output, to ensure implementation of the production plan.
按照标准操作程序完成生产区域的物料相关操作,如货物装卸/清洁、物料转移、成品入库、包材退库、废品管理等操作,及时完成操作过程的记录填写和系统数据的输入和输出,保证生产计划的实施;
Keep abreast of the production area,to ensure the mateiral supple,aviod production delay due to material issues.
及时了解各生产工序的生产情况,保证物料的正常运作,完全避免因物料问题而产生的生产延误;
Classifying production areas of waste and handle in time, ensure the hazardous waste and the effective control of nonconforming product, and all operation need meet the GMP and EHS requirements.
及时对生产区域废品进行分类和处理,确保危险废品和不合格品的有效控制,并符合GMP和EHS的相关要求;
Perpare and use of logistics facilities or tools by SOP,such as forklifts,pallet,conveyor belt,packaging machine,etc., and regularly check to ensure that they are in good running condition.
按照程序要求准备和使用物流设施或工具,如叉车、托盘、传送带、裹包机等,并定期进行检查,确保其处于良好的运行状态;
Formulation and in accordance with standard operating procedures to complete the production mold and the corresponding area of the maintenance of equipment components, make sure that all of the record of operation process and system data input and output, to ensure the implementation of production plan.
按照标准操作程序完成生产区域的模具及相应设备部件IBC的清洁,发放,存储;确保操作过程的记录填写和系统数据的输入和输出,保证生产计划的实施;
Understand each production unit production situation in time, ensure the maintenance and normal recipients, to avoid production delays due to toolings cleaning state issues.
及时了解各生产单元的生产情况,保证模具和IBC及时维护及正常领用,避免因模具状态问题而产生的生产延误;
Follow the production schedule, Configure the cleaning agent and disinfectant.
根据计划,负责区域内的清洁剂,消毒剂的配制及分发;
Make tooling of PKG、MFG cleaning and maintenance.
包装、制造模具的清洁维护保养;
Based the standard of 5S, keep and ensure the work floor meets the 5S standard.
依据部门5S要求,维护并确保现场符合5S的管理规范;
Timely and appropriate adjustment for tooling storage areas and planning, ensure a higher space utilization and clear distinction between isolation, labeling, in order to meet the GMP, EHS and other regulations or procedural requirements.
对负责区域进行及时、适当的调整和规划标示,以满足GMP、EHS等相关法规或程序的要求;
岗位所需技能,绩效及能力:
1) Performances 绩效
Unsafe behavior不安全行为
Human error人为错误偏差
Customer satisfaction客户满意度
Good execution. / 良好的执行力
2) Skills required技能要求
Good execution skills良好的执行力
Good GMP knowledge良好的GMP意识
Good team work良好的团队配合
Good communication skills良好的沟通技巧
Good computer skills熟练使用电脑
3) Competences & Backgroud能力及背景
Pharmaceutical or mechanical college degree or above.
有制药或机械相关大专或以上文化程者优先;
More than three years working experience in medicine, food, cosmetics production enterprise is responsible for, familiar with production enterprise production workshop operation.
有在医药、食品、化妆品生产企业负责两年以上工作经验者优先,熟悉生产型企业的生产车间运作;
Familiar with GMP requirements.
熟悉GMP相关要求者优先;
Production of pharmaceutical dispensing and machinery maintenance experience is preferred.
有制药配方称量以及机械维护经验者优先;
Have forklift operation license is preferred.
有叉车作业许可证为佳。
Production of molds and machinery maintenance experience is preferred.
有生产模具以及机械维护经验者优先。