Dynavax Technologies

  • Senior Specialist QA Validation (m/f/d)

    Job Locations DE-NW-Düsseldorf
    Job Post Information* : Posted Date 1 week ago(7/11/2018 6:27 PM)
    Req. #
    HP-232
    # of Openings
    1
    Category
    Quality Assurance
  • PRIMARY PURPOSE OF POSITION

    In this role, you will support the Quality Assurance organization at Dynavax Düsseldorf manufacturing facility. This role requires the successful candidate to:

    MAJOR DUTIES OF POSITION

    • To support or contribute the preparation, review, and approval of qualification and validation related documents
    • To ensure that appropriate quality standards are applied in accordance with regulatory, corporate and industry requirements.
    • To assist in and drive quality-related activities including the preparation, review, and approval of cGMP documentation.
    • To perform or assist in general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, generation of technical reports, and reporting of quality metrics.
    • To participate in meetings to report on, contribute to, and / or resolve quality-related matters and represent QA in various internal and external meetings to provide QA - related expertise

    KNOWLEDGE AND SKILL REQUIREMENTS

    • Bachelor’s degree or higher in Biology, Chemistry, Engineering, Industrial Management, Operations, Quality, or Manufacturing (other degrees in combination with relevant experience acceptable) or equivalent experience in pharmaceutical industry.
    • 5+ years of relevant work experience in Quality Assurance or in combination with relevant education.
    • Experience in qualification and/or validation practices
    • Experience in Quality Assurance for Validation
    • Working knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and drug products
    • Good understanding of cGMPs, industry and regulatory standards and guidelines
    • Excellent interpersonal skills
    • Experience working with cross-functional teams
    • Strong ethical foundation and a sound compliance understanding
    • Mandatory business fluent in English, German fluent preferred

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