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BABavarian Nordic Berna GmbH

CSV Professional in QC(m/w/x)

Bern
Full-timeOn-siteExperienced

CSV activities for analytical equipment qualification in vaccine QC. cGMP experience and fluent English/German required. Exceptional technology, personal growth support.

Requirements

  • Scientific, technical, or related background
  • Professional experience in cGMP-regulated environment
  • Fluent English and German
  • Advantageous: CSV, data integrity, computerized systems administration in cGMP

Tasks

  • Ensure compliance of QC processes and equipment
  • Support implementation of data integrity requirements
  • Manage administration and lifecycle of computerized systems
  • Serve as process owner for analytical equipment qualification
  • Lead CSV activities in QC
  • Maintain validated status of local LIMS
  • Administer and review local LIMS periodically
  • Coordinate system changes within local LIMS
  • Support computerized system validation activities
  • Represent QC data governance during inspections and audits

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishFluent
  • GermanFluent

Benefits

Modern Equipment

  • Exceptional technology

Other Benefits

  • Determined team

Startup Environment

  • Vibrant and adaptable work environment

Learning & Development

  • Support for personal and professional skills growth
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