QA Associate Manager (Quality Operation)质量保证副经理(质量运营)

Posted 24 Apr 2020

Beijing - all, Beijing - China

Req Id 205608


在默克我们企业的职业生涯是一个不断的发现之旅:我们约 56000 名员工正塑造着全球的生活、工作和娱乐方式,通过下一代医疗保健、生命科学与高性能材料领域中的进步。350 多年来,横跨全世界,我们热切地追求我们的好奇心,以便找到创新和充满活力的方式来改善他人的生活。

Your role:

Product disposition management:

  • Establish and maintain product quality archive; Maintain product list; Complete LEAN SAP system setting correctly and timely to meet the business requirements;
  • Perform the goods accept inspection according to local procedure;
  • Supervise and ensure the responsible person of importer/3PL to perform the operation as required, verify the problem during goods examination step;
  • Product inspection and disposition for the local market;
  • Verify the reject product and monitor the handling process to ensure the handing meet requirement of Our company and regulation;
  • Translate and archive site CoA of chemical drug;
  • Import QC re-test support, including reference standards and lab material supply and management;
  • Monitor implementation of the drug traceability system;
  • Guide and monitor the quality management of steps: purchase, storage, maintenance, sale, return, transportation etc.;
    Primary distribution management:
  • Evaluate the shipping temperature data of temperature sensitive products and keep the product under appropriate status
  • Implement monthly RFT (Right First Time) review meetings with DHL to analysis, monitor and improve RFT performance
  • Track the destructions due to deviation of primary distribution and set up baseline.
    Secondary distribution management:
  • Supervise the product transportation which was performed by SNO and forwarder to ensure meet requirement of Our company and regulation;
  • Local shipping routes management, ensure all used shipping routes be approved;
  • Coordinate the concurrent shipping route validations actions to push them are completed according to 2020 VMP (both in summer and winter), ensure the validation meet requirement of Our company and regulation;
  • Implement shipping temperature data monthly review and make CAPA if needed to ensure continuous improvement;
  • Improve and perform shipping temperature data review plan for the shipment by importer/3PL and distributors to ensure meet requirement of Our company and regulation;
    Import/3PL/Forwarder management:
  • Organize the regular communication and on-site inspection to importer/3PL and forwarder with SNO to ensure their operation meet requirement of Our company and regulation;
  • Update KPI with SNO to ensure KPI meet both global and local business requirements.
  • Monitor KPI and set up follow up action list to ensure continuous improvement.
  • Ensure the validation and calibration of the importer/3PL and forwarder meet requirement of Our company and regulation;
    PQS and Projects:
  • Establish and update quality operation related SOP/WI;
  • Deviation management and training of deviation and investigation;
  • Product recall management and organize mock recall;
  • Responsible for handling QO related Alert;
  • Support LEAN QM Module phase 2 development project
  • DTP(Direct to Patient Pharmacy ) project supporting;
    Who you are:
    •      Licensed Pharmacist (Mandatory)
    •      Bachelor degree or above in pharmacy, biology, chemistry or related majors.
    •      At least 5 years working experiences in drug manufacture and/or distribution area
    •      Experience of working in QA area in multinational companies is preferred
    •      Fluent English in listening, speaking, reading, and writing.
    •      Be familiar with SAP operation and logistic
    •      Good communication skills
    •      Professional knowledge in GDP(GSP)/GMP
    •      Problem solving ability and skill
    •      Ability to face challenge and self-learning
    HR: 95601
    Functional Area: Quality



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