QA Specialist 北京

月薪： 1-1.5万/月

该公司所有职位
  • 无工作经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Functional Tasks职能性任务:?To maintain and develop local quality assurance system based on MSQ standards and with the local Medical Device (including IVD) regulatory;依据默克生物制药总部质量部门标准，当地的GDP (GSP) / GMP和医疗器械(包括体外诊断试剂)相关法律法规，维护和开发本地的质量保证系统；?Develop and maintain the local SOP based on quality related corporate policies, guidelines, procedures and local GDP (GSP)/GMP requirements;基于集团质量方针，指南，规程和当地的GDP/GMP法规要求，开发和维护本地质量文件；?Responsible for the examination and acceptance of drug and Medical Device(including IVD), supervise and ensure the responsible person of the third party to perform the operation as required, verify the problem found in examination step;负责药品和医疗器械(包括体外诊断试剂)的验收，监督和保证第三方验收人员按要求进行验收，对验收中发现的问题进行确认；?Responsible for providing Medical Device (including IVD)after-sales service and handle the quality complaint;负责医疗器械(包括体外诊断试剂)的售后服务以及处理投诉；?Responsible for reporting and handling AE of Medical Device (including IVD);报告和处理医疗器械(包括体外诊断试剂)的不良事件；?Establish and maintain product quality archive and update the product quarterly;建立和维护产品质量档案,季度性的更新产品清单；?Responsible for evaluation and release of temperature sensitive products;负责温度敏感产品的评估和放行；?Supporting management of drug Track & Trace code;支持药品追溯系统的管理；?Responsible for the record temperature deviation and investigation;负责记录本地温度偏差以及相关调查；?Review and analyze the KPI with 3PL or importers;与第三方或进口商定期回顾和分析KPI；?Local QC supporting，including providing reference standard and QC material, and coordinate the test process;为本地的药品检验所提供对照品以及实验耗材服务，协调反馈试验情况；?Perform other tasks as required or assigned.完成领导指派的其他任务。EDUCATION/LANGUAGES教育背景/语言?Bachelor degree or above in medical / clinical examination, pharmacy ,biology or related filed;医学检验、临床检验、药学、生物学或其他相关专业大学本科或以上学历；?At least 3 years working experiences in quality management of Medical Device (Including IVD); 医疗器械（包括体外诊断试剂）质量管理3年以上工作经验；?Working experiences in Medical Device (Including IVD) ，Drug GMP or GSP area is preferred; 医疗器械（包括体外诊断试剂）或药品GMP / GSP 工作经验优先；?Experience of working in QA area in multinational companies is preferred;跨国公司QA工作经验优先；?Good English skill at listening, speaking, reading and writing.良好的英语听、说、读、写能力。PROFESSIONAL & TECHNICAL SKILLS专业技术能力?Chief inspector is mandatory, or at least had Bachelor degree in medical / clinical examination and at least 3 years working experiences in clinical examination experience; 必须具备主管检验师资质，或至少具有检验学相关专业大学以上学历并从事检验相关工作3年以上工作经历；?Licensed Pharmacist is preferred;执业药师资质优先；?Working experience in clinical lab is preferred;医院检验科工作经验优先；?Working experience in drug QC lab is preferred;药品分析检测工作经验优先；?Fluent in SAP is preferred;熟悉SAP系统操作优先；?Professional knowledge in quality management area of Medical Device (Including IVD); 具备医疗器械（包括体外诊断试剂）质量管理领域的专业知识；?Good communication skills of both scientific and non-scientific information;良好的沟通技巧；?Problem solving ability and skill;具有解决问题的能力和技巧；?Ability to face challenge and self-learning;应对挑战和自我学习能力；?Team work and coordinate in cross-functions;团队合作和跨部门协调能力。 职能类别： 医疗器械生产/质量管理 供应商管理 关键字： QA medical device GSP SAP suppliers clinical pharmacy

联系方式

北京市朝阳区

公司信息

默克雪兰诺有限公司 默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。 默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。

北京相关职位
猎才二维码