Dynavax Technologies

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

    Job Locations DE-NW-Düsseldorf
    Job Post Information* : Posted Date 4 months ago(7/11/2018 6:26 PM)
    Req. #
    HP-231
    # of Openings
    1
    Category
    Quality Assurance
  • PRIMARY PURPOSE OF POSITION

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

    MAJOR DUTIES OF POSITION

    • Oversight of Change Control, Deviation Management and CAPA process Quality System Performance
    • Evaluation and approval of Deviations, CAPAs and Change Control requests, and follow-up on actions needed to close
    • Change Control review and approval, including evaluating of their influence on the quality of the product
    • Review documentation associated with deviations including notifications, investigation reports, risk analysis, and protocols/reports. Evaluate the influence of deviations on product quality.
    • Manage day to day CAPA program including the review and evaluation of their effectiveness on the quality of pharmaceutical product
    • Review Work Orders, as required
    • Assist in quality-related activities including the review and approval of GMP documentation
    • Participate as a member of the investigation team, when required
    • SOP collaborator and approver, when required

    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 may be considered)
    • 5+ years of relevant work experience in Quality Assurance
    • Working knowledge of current federal, local and international regulations
    • Good understanding of cGMPs, industry and regulatory standards and guidelines, strong ethical foundation and a sound compliance understanding.
    • Thorough knowledge and understanding of Deviations/CAPAS/Change Controls
    • Experience in reviewing and approving GMP related documents (i.e., SOPs, Protocols, Validation Reports, etc.)
    • Excellent leadership and interpersonal skills, including collaboration, communication and training skills as well as organizational skills and attention to detail
    • Excellent ability to prioritize and manage multiple projects and tasks
    • Personal attributes include flexibility, integrity, action and goal oriented
    • Business fluent in German and English

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