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Hangzhou

    MQA Engineer - Hangzhou, 中国 - Abbott Laboratories

    Abbott Laboratories
    Abbott Laboratories Hangzhou, 中国

    发现在: beBee S2 CN - 2小时前

    Abbott Laboratories background
    OTHER
    描述

    MAIN PURPOSE OF ROLE

    • Batch Record review and finished product release
    • Track and analyze the production trend, to improve the efficiency of batch record and production performance
    • To monitor the manufacturing process timely catching up any issues during production, and communicate with cross functions for the trouble shooting from quality standpoint, making sure the compliance status of execution
    • Onsite monitoring and improve of manufacturing shop floor GMP

    MAIN RESPONSIBILITIES

    • Track, maintain and analyze the batch record, cooperate with cross team for the improvement opportunity of batch record, and coordinate for finished product release.
    • To monitor the manufacturing process timely catching up any issues during production, and communicate with cross functions for the trouble shooting from quality standpoint, making sure the compliance status of execution.
    • On line quality management for production, and develop proper procedure to guide the new issues according to actual production. Online monitoring for manufacturing shop floor GMP, supporting & following the improvement.
    • Coordinate with cross departments for the trouble shooting, like work order, manufacturing, packaging and so on.
    • Individually evaluate the impact of the finished product, and be a decision maker.
    • Perform external document assessment.
    • Observe issues independently, and trouble shooting for them by using quality tools, like RCA and 5WHY.
    • Undertake other quality assurance responsibilities.

    QUALIFICATIONS

    • Education: Bachelor Degree and above in f or related discipline or Diploma
    • 3+ years' quality experience in pharmacy or medical devices industry
    • Other qualifications/certifications:
    • Familiar with the regulation code of ISO9000, ISO13485, GMP, 21CFR820, IVDD, IVDR Regulation, etc. FDA audit experience is preferred.
    • Ability to work in a highly matrixed and geographically diverse business environment.
    • Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
    • Strong organizational, communication and coordination skills, as well as attention to detail.