Senior Specialist QA Operations (m/f/d)


  • Company:
    Dynavax Technologies
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    6 days ago
  • Category:
    Customer Service

In this role, you will support the Quality Assurance organization at the Dynavax Düsseldorf manufacturing facility. This role requires the successful candidate to:Oversight of Change Control, Deviation Management and CAPA process Quality System PerformanceEvaluation and approval of Deviations, CAPAs and Change Control requests, and follow-up on actions needed to closeChange Control review and approval, including evaluating of their influence on the quality of the productReview 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 productReview Work Orders, as requiredAssist in quality-related activities including the review and approval of GMP documentationParticipate as a member of the investigation team, when requiredSOP collaborator and approver, when requiredBachelor”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 AssuranceWorking knowledge of current federal, local and international regulationsGood 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 ControlsExperience 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 detailExcellent ability to prioritize and manage multiple projects and tasksPersonal attributes include flexibility, integrity, action and goal orientedBusiness fluent in German and English