Dynavax Technologies

Senior QA Specialist Quality Operations m,f

DE-NW-Düsseldorf
4 weeks ago
Req. #
HP-214
# of Openings
1
Category
Quality Assurance

MAJOR DUTIES OF POSITION

In this role, you will support the Quality Assurance organization at the Dynavax Düsseldorf manufacturing facility. Tasks include Quality Operations oversight and review. This role requires the successful candidate to:

  • 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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