QA Specialist 质量保证专员

Job Summary职位概述:
1. Responsible to maintain an******** the quality system, workingproce******** to monitor the implementation an********, to ensure thecompliance with local an******** 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 an******** 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 an********controll******** new product an******** an******** ******** establishan******** product file an********, distributor management, guide onGxP relate******** in computer system to ensure compliance with RDquality standards an******** 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 an******** on product purchas******** incoming goo********maintain the goo******** sales, return , non-conformity productmanagement, transportat******** CFDA product tracebility system reportetc. , coordinate to monitor an******** 3PL conditions an********assurance capabilities;
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 standar******** product Chinese labelan********, taking quality control in proce******** to ensure thecompliance with regulations.
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 an******** Control. Keepsrecords. Has clear filing an******** 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 Businessan******** 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. License******** 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 an******** English
熟练掌握英语口语及书面表达
3. Goo******** of MS office software application
熟练应用微软办公软件
4. Understan******** device an******** 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 exper******** especially in QA management, GSPan******** 9000 cert******** keep goo******** with authoritiesan********.
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 an********, work har******** earnest
具有强烈的事业心,工作仔细认真
3. Willing to work under pressure, self-starting an********-inspiring
能承受高强度的工作压力,积极主动并自我激励
4. Be honest an********, excellent interpersonal communicationsk******** ability of social activity an********
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 goo******** 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