Integra LifeSciences

  • QC Specialist

    Vacancy ID
    2018-26386
    Location
    JP-Tokyo
    Position Type
    Regular Full-Time
    Category
    Quality Assurance
  • Overview

    QC Specialist will be responsiblie for below 2 main areas working closely with QA team.

    • Product Release and Distribution
    • Quality System Management

    *This QC Specialist position is based in Tokyo, Japan, and recquires native or near native Japanese language skill and a proper working visa.

    Responsibilities

    Product Release and Distribution

    • Perform in-coming QC and release Integra products in compliance with PMD Act
    • Perform in-coming testing (if required)
    • Perform labeling for products in compliance with PMD Act
    • Perform packaging (if required)
    • Validation for defect products and report
    • Report defect product to manufacturer
    • Resolution of quality issue and CAPA
    • Perform product recall
    • Process validation (if required)
    • Manage inspection equipment
    • In-coming check for defect products from customer

    Quality System Management

    • Prepare/revise/control SOPs and forms to ensure compliance with Japan QMS requirements.

    Qualifications

    Education and Experience

    • Bachelor's degree
    • Degree in pharmacy or scientific field
    • Minimum 5 year QC experience in Pharmaceutical / Medical Device (Class IV) Industries

     

    Essential Skills and Abilities

    • Excellent verbal and written communication skills
    • Ability to multiple tasks, prioritize and work under pressure
    • Strong negotiation skills with Japan authorities (MHLW, PMDA, TMG, Notified body)
    • Good organization skills and ability

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