QA Officer - BIO Section (Thang Long I IZ, Hanoi)ID:28839

20,000,000 VND ~ 24,000,000 VNDKhu công nghiệp Thăng Long Ikhoảng 20 giờ trước

Tổng quan

  • Mức lương

    20,000,000 VND ~ 24,000,000 VND

  • Ngành

    Medical

  • Mô tả công việc

    - Perform and supervise daily Bio Lab activities and microbiological testing; Conduct bioburden, endotoxin, sterility testing and environment monitoring; Make record, review and report test results accurately and timely
    - Perform/Support the preparation and revision of SOPs, test method and validation documents; Ensure testing activities comply with SOPs, ISO 13485 and applicable qualiy requirements;
    - Perform/Support invesigations of OOS/OOT, deviations and abnormal test results, including NCR, CAPA activities … Maintain laboratory equipment, materials, reagents and related records;
    - Train and support Bio Lab members to ensure technical competency; Support Bio Lab acitivities and technical transfer at overseas facilities when required

Trình độ

  • Yêu cầu

    {MUST}
    - Bachelor’s degree or higher in Microbiology, Biology, Biotechnology, Biochemistry or related fields
    - English: At least Intermediate level
    - Having at least 5-7 years of relevant experience in microbiology/ Bio laboratory operations
    - Strong practical experience in bioburden, endotoxin, inhibition, Gas Chromatography, sterility testing and environment monitoring …
    - Good knowledge of ISO 13485, 10993-7, 11737-1/2, 11135, 14644/14698, GMP/GLP, microbiological testing and laboratory quality systems;
    - Experience in team leadership, laboratory management, equipment management and handling OOS/OOT, deviations, root cause analysis and CAPA;
    - Strong analytical, problem-solving, communication and cross-functional collaboration skills
    - Willing and able to undertake long-term overseas business trips/ assignments as required;

    {PREFER}
    - Preferably in the medical device or pharmaceutical industry
    - Having Japanese/Chinese skill

  • Tiếng Anh

    Intermediate Level

  • Ngôn ngữ khác

    None

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