QA Specialist 质量保证专员

面议 上海 3-5年 本科 全职
罗氏诊断产品(上海)有限公司 2017-01-22 更新 2017-03-15 截止

QA Specialist 质量保证专员

职位描述
Job Summary职位概述:
1. Responsible to maintain and update the quality system, workingprocedure, to monitor the implementation and documentation, to ensurethe compliance with local and global regulations.
按照当地法规及总部要求,维护更新质量管理制度、工作程序,并监控其实施及记录情况
2. Fulfill the company SOPs, regulatory and quality control
执行公司质量管理规定进行质量法规控制工作

Main Tasks & Responsibilities主要工作职责 :
1. Coordinate with other departments on regulatory and qualitycontrolling, new product and provider and customer qualification,establish and maintain product file and categories, distributormanagement, guide on GxP related content in computer system to ensurecompliance with RD quality standards and local regulations.
与其他有关部门协调处理质量法规控制工作,负责首营审核、建立并更新所营产品的质量档案和目录清单,经销商管理,参与指导设定计算机管理系统中有关质量控制的相关内容等工作,确保符合相关当地法规要求和总部质量要求。
2. Guide and supervise on product purchasing, incoming goods, maintainthe goods, sales, return , non-conformity product management,transportation, CFDA product tracebility system report etc. ,coordinate to monitor and assess 3PL conditions and quality assurancecapabilities;
指导并监督产品的验收采购、收货、储存、养护、销售、退货、不合格品管理、运输、产品追溯系统的申报等环节的质量管理工作,协助监督考核委托的第三方物流公司储运条件和质量保障能力
3. Responsible for issuing standard of product Chinese label and PI,taking quality control in procedure, to ensure the compliance withregulations.
负责产品中文标签和中文说明书标准发布及流程质量控制,确保符合法规要求
4. Check the promotion material to ensure the compliance withregulations.
对市场部推广材料审核,确保符合法规要求
5. Quality Documents & Records Control and Change Control. Keepsrecords. Has clear filing and maintain of all documents.质量文件、记录的控制及变更文件的控制。文件分类归档,保留完好
6. Conduct business in full compliance to Behavior in Business andBehavior in Competition
遵循商业行为准则,合法合理开展业务活动

Basic Requirements of the Job基本任职资格:
Education& Qualifications教育背景与专业资格:
1. Bachelor degree or above, subject on Medical/pharmacy/ clinicallaboratory. Licensed pharmacist or lab technician in charge preferred.
本科以上学历, 临床检验或医学等相关专业。具有执业药师或检验师职称优先
2. Proficiency in both spoken and written English
熟练掌握英语口语及书面表达
3. Good command of MS office software application
熟练应用微软办公软件
4. Understand medical device and IVD regulation
了解医疗器械及体外诊断试剂相关法规

Experience工作经验:
1. Have above 3 years experience, especially in QA management, GSP andISO 9000 certification, keep good relationship with authorities andofficials.
3年以上工作经验,有质量管理和GSP, ISO9000 认证方面的经验,与相关政府部门关系良好
2. High enthusiasm and devotion, work hard and earnest
具有强烈的事业心,工作仔细认真
3. Willing to work under pressure, self-starting and self-inspiring
能承受高强度的工作压力,积极主动并自我激励
4. Be honest and open, excellent interpersonal communication skill,ability of social activity and collaboration
为人诚实、开朗,善于与人沟通和合作, 有较强的社会活动能力
5. Innovating with good independent working ability
在工作中不断创新,能独立处理问题
6. Energetic team spirit
有团队合作精神
职位要求
  • 临床医学

  • 本科

  • 3-5年

工作地址

上海

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联系人
廖经理 china.diagnostics@roche.com
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