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

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:
    EDUCATION/LANGUAGES
    •      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
    PROFESSIONAL & TECHNICAL SKILLS
    •      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
职位需求编号:  205608
位置:  北京 - 全部
职业阶段:  D - 工作年限(4 - 9年)
工作时间模型:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


职位细分: Assistant Manager, ERP, CAPA, Pharmacy, Management, Quality, Technology, Healthcare

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