Johnson & Johnson Careers

Specialist Quality Assurance

Hangzhou, China

Job Description

Requisition ID: 1805646071W

质量体系维护和推行: Quality System Maintain and Implementation
  1. 收集更新外部法规要求如ISO, FDA QSR 820, GMP标准和加拿大,欧盟GMP等。
    Collect and Update the external regulatory, eg. FDA QSR 820, GMP and Canada, EU GMP etc.
  2. 按照外部法规要求维护和改进质量体系以保证符合要求。
    Maintain and improve quality system to meet compliance with external regulatory.
  3. 收集内部和中国法规要求:如中国药品法规、中国医疗器械法规、中国卫生系统法规,和总部法规要求等。
    Collection of internal and regulation requirements in China: Such as China's drug regulation, medical device Regulation, Hygiene system regulations, and the headquarters of regulatory requirements etc.
  4. 按照内部和中国法规要维护和改进质量体系以保证符合要求。
    In accordance with the internal and Chinese regulations to maintain and improve the quality system to ensure compliance.
  5. 按照中国法规机构要求及时通过相应信息:如申报、备案等。
    In accordance with the requirements of regulatory agencies in China, pass appropriate regulations requirements: such as information submit regulation authorities and so on.
  6. 准备并组织质量管理评审,小结并跟踪质量管理评审的输出及实施。
    Prepare and support quarterly management review, summarize the output of QMR and tracking the implementation of relevant action plan.
Support quality audit and follow the closure of observations.
  1. 负责所有法规检查和内部审计的准备工作,协调各部门的审计准备。
    Be responsible of the preparation of regulatory audit and internal audit. Coordinate the inspection readiness of each department.
  2. 组织协调法规审计和内部审计。
    Coordinate regulatory inspection and internal inspection.
  3. 跟踪审计发现项(含near miss)的及时回应和相关行动计划的按时完成。
    Tracking the on-time delivery of response to the observations and follow the implementation of associated action plan.
质量体系相关的项目 Quality system related project
  1. 参与质量体系相关的项目,以及分配的其它项目,可能与文件系统相关,也可能质量体系内的其它系统。
Participate quality system related project and assigned other projects. The scope may fall in the documentation control system, but not limited to the doc. control system.
其他: Others
  1. 支持GMP 培训、文件管理以及产品批记录的审核。
Support GMP training, document management and product batch record review.
  1. 主管安排的其它任务。
    Other work assigned by supervisor

  1. 药学、化学或相关专业本科学历,或两年以上制药或医疗器械行业质量部门工作经验, 具制药/医疗器械行业质量保证工作经验者佳。
    Bachelor degree, major in pharmaceutical or chemistry or other related discipline. Or a minimum of two years work experience in quality department in pharmaceutical/medical device industry, experience of quality assurance will be preferred.
  2. 熟悉质量管理体系;熟悉质量管理工具的应用。
    Familiar with quality management system, and the quality tools implementation.
  3. 熟悉相关国家和地方质量政策法规(GMP,ISO,药监局,药检所等)
    Familiar with relevant National and local quality regulation.( GMP, ISO, cFDA, IDC)
  4. 电脑办公及业务软件的使用能力
    Familiar with the Office software and other professional software.
  5. 英语水平较好(书写、阅读相当于4级)
    English level CET- 4 for oral and reading.
  6. 熟悉质量系统
    Knowledge of quality system
  7. 仔细和认真,责任心强
    Work hard and earnest
  8. 良好的沟通、协调能力
    Good communication and coordinating skill
  9. 计算机文档管理能力强。
    Knowledge of managing documentations with computer
  10. 熟悉基本办公软件的使用。

Primary Location
AMO (Hangzhou) Co., Ltd. (7077)
Job Function
Requisition ID