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Specialist QA Compliance and Sterility Assurance 80 - 100% (f/m/d)

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Offered by:

Bavarian Nordic Berna GmbH

Medical
Thörishaus

Responsible, as QA representative in multidisciplinary teams, to oversee the following topics:

  • Deviation, Change Control, CAPA Management
  • Sterility Assurance and Contamination Control
  • Process Validation

 What is in the role for you:

  • Reviews and approves deviations, investigations, CAPAs and Change Controls
  • Reviews and approves process validation documents including risk assessments
  • Oversees site manufacturing activities (oral and parenteral) concerning sterility assurance
  • Owns the Contamination Control Strategy documents of the site
  • Establishes annual Product Quality Reviews
  • Establishes and approves trend reports
  • Ensures regulatory compliance and continuously improves the allocated quality systems and procedures
  • Participates in audits and inspection within the area of responsibility

What do you bring to it:

  • Master’s degree preferrably in Life Sciences or related field with track record in Microbiology and Sterility Assurance
  • Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry
  • Solid computer skills including MS Office required / SAP, LIMS, Quality Management Systems skills are a plus
  • Analytical thinking and problem-solving attitude
  • Multilingual – at least German and English, written and spoken

 We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile QA team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills. Additionally, we offer an extensive benefits package and a competitive compensation package. Caught your interest? We look forward to receiving your application directly on our recruiting portal: https://candidate.hr-manager.net/ApplicationInit.aspx?cid=1576&ProjectId=146883&DepartmentId=18972&SkipAdvertisement=true