招聘信息

• QA工程师

  面议 浙江省杭州市钱塘区 全职 本科 2人 2025-06-30

  收藏 投递简历

  2025-03-25 14:01:12

  职位描述

  
  

  学历要求：本科

   专业要求：制药工程相关专业

   核心要求：

    1. 熟悉GMP质量管理体系，能够在指导下监督相关制度和计划的执行。

    2. 具备良好的英语能力，能够快速完成文件翻译和校对工作。

    3. 能够参与偏差调查、CAPA处理以及内外部审计工作，确保质量合规。

  职责：

  
  

  1.日常质量管理职责包括但不限于： 
  Routine quality management responsibilities include but are not limited to:
  1.1负责日常QA相关的客户信息传递和跟踪，组织会议、口译、会议纪要的撰写； 
  Responsible for routine QA related customer information transfer and tracking, and responsible for meeting organization, interpretation and meeting minutes writing;
  1.2参与外部客户或官方对于相关质量体系的要求或信息的传递，包括英文翻译； 
  Participate in the communication of external customer or authority requirements or information on the relevant quality system, including English translation;
  1.3负责监督质量管理体系相关制度和计划的执行及实施； 
  Responsible for supervising the implementation of relevant systems and plans of quality management system;
  1.4参与质量管理体系文件的编制、审核以及改进，并负责岗位相关体系文件的编制和执行； 
  Participate in the preparation, review and improvement of quality management system documents, and responsible for the preparation and implementation of relevant system documents in the position;
  1.5负责质量管理体系文件、体系汇总表及相关报告的翻译/校对； 
  Responsible for translation/proofreading of quality management system documents, system summary lists and related reports;
  1.6参与偏差、CAPA、变更、OOS/OOT、审计发现项等体系事件的调查处理；
  Participate in the investigation and handling of deviations, CAPA, change control, OOS/OOT, audit observations and other system events;
  1.7参与内外部审计工作的组织和实施、各类质量审计缺陷整改回复； 
  Participate in the organization and implementation of internal and external audit work, and replying corrections of quality audit observations;
  1.8参与GMP事务申报资料的收集和编写； 
  Participate in the collection and preparation of GMP affairs application files;
  1.9负责识别最新质量法规，组织新法规的合规性分析以及合规行动的制定；
  Responsible for identifying the latest quality regulations, organizing the compliance analysis of new regulations and the formulation of compliance actions;

  职位类别:质控/安检

  专业要求:理学

单位简介