面议
苏州工业园区 | 10年以上经验
发布时间:2020-01-22 09:18:53 | 截止时间:2020-04-17
基本信息:
  • 质量管理/测试经理(QA/QC经理)
  • 有经验要求
  • 全职
  • 1
  • 质量部
职位描述及要求:
  • Main Duties:
    - Establish and maintain quality control management system and ensure its compliance to cGMP and international regulations (e.g. 21CFR Part 211, EU GMP, China GMP, ICH).
    - Review or approve specification and test method of component and drug product and ensure analyst understand their requirements and implement their analysis according to effective method.
    - Review or approve protocol or report of method transfer, method verification or method validation to make sure test method is verified or validated before use.
    - Review or approve drug product stability study protocol, time point report and final report, identify potential atypical trend if applicable and work with other function (e.g. QA and Production Dept.) if necessary for investigation and root cause determination.
    - Participate in material supplier/contract laboratory due diligence, trial study and qualification evaluation.
    - Ensure all instrument in laboratory is qualified or calibrated before use.
    - Participate in utility qualification, process validation or cleaning validation/verification and make sure lab can support all required test activities according to protocol.
    - Responsible for laboratory OOS, OOT and atypical data investigation and make sure root cause is identified, quality impact is thoroughly evaluated and relevant CAPA(s) is prepared for continuous improvement.
    - Review or approve change control in laboratory area, well assess its impact and prepare implementation step(s) to execute change and minimize or mitigate potential risk.
    - Review or approve computerized system validation protocol and make sure system is validated before use and CS validation is compliant to cGMP requirement.
    - Establish data integrity management program and ensure integrity of all test data (paper or electronic) and documentation.
    - Responsible for utility system (e.g. purified water/HEPA) routine monitoring and work with EG dept. to make sure class D environment is maintained and systems are in qualified status.
    - Responsible for instrument requalification program and computerized system periodic review program to make sure equipment and system is maintained in qualified or validated status.
    - Responsible for QC staff’s daily work assignment, training/coaching and performance management.
    - Coordinate all GMP activities, including but not limited to
    Material and drug product test schedule
    Test activities in outsourced contract laboratory/Service provider
    Stability study schedule
    - Responsible for other duties assigned by supervisor.

    Minimum Requirements:
    - Bachelor degree or above with major of Chemistry, science in pharmacy or relevant
    - At least 10 years’ working experiences in QC area of drug product manufacturing site(MNC dry product manufacturing site is preferred)
    - Solid GMP knowledge of cGMP of US, EU and China
    - Good technical skills of quality control in pharmaceutical industry
    - Strong capability of leadership and strategic thinking
    - Good communication and negotiation skill
    - Fluent oral English and Good written English
岗位条件:
  • 本科
  • 英语 精通
  • 医药卫生类>药学
  • 不限
您也可以使用手机扫描二维码分享这个职位给朋友们
  • 外商独资、外企办事处
  • 制药/生物工程
  • 苏州工业园区东平街188号A幢
给我留言:
最近浏览
职位推荐
    服务热线
    400-6000-600
    工作日9:00-17:30
    扫码访问手机圆才网
    扫码关注微信公众号