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BABavarian Nordic Berna GmbH

Quality Assurance Specialist Qualification(m/w/x)

Bern
Full-timeOn-siteExperienced

QA representation in multidisciplinary teams for life-saving vaccine development. 5 years GxP pharma/biotech experience, 3 years validation/qualification required. Hands-on risk assessments for equipment and facilities.

Requirements

  • Master’s degree in Engineering, Biotechnology, or related field
  • Minimum of 5 years relevant experience in GxP regulated pharmaceutical/biotechnology industry
  • Minimum of 3 years validation and qualification experience
  • Solid computer skills including MS Office
  • Analytical thinking and problem-solving attitude
  • Ability to work independently
  • Fluency in German and English, both written and spoken

Tasks

  • Act as the QA representative in multidisciplinary teams
  • Provide guidance on quality assurance practices
  • Ensure compliance with regulatory requirements
  • Oversee and approve qualification and validation documentation
  • Conduct risk assessments for equipment and facilities
  • Support the implementation of qualification strategies for equipment and utilities
  • Assist in the transition from project to commercial production phase
  • Ensure compliance of quality systems with regulatory expectations
  • Establish and improve quality procedures in your area of responsibility
  • Continuously enhance allocated quality systems
  • Support changes and corrections within your area
  • Participate in audits and inspections related to your responsibilities

Work Experience

  • 3 years

Education

  • Master's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic Berna GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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