Experte Methodenetablierung - Validierung (w/m)

Job-ID:500ATT


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Description

  • Assure GMP compliant and timely execution of QC test method validations/qualifications for QC test method implementation and
    maintenance
  • Write protocols and reports for method validation, method transfer and comparability studies as well as qualification documents for standards and reagents, and implementation of method controls
  • Plan the concept and ICH conform method validations together with QC testing labs
  • Support global harmonization and simplification
  • Lead and drive analytical assay investigations (OOS, CAPA, etc)
  • Knowledge sharing of problems that were found and share solutions to drive continuous improvement


Qualifications

  • Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
  • Expertise with HPLC-based analytical methods
  • Know how of other analytical methods such as ELISA, spectroscopy, PCR and microbiological tests
  • Knowledge about analytical method validation and critical reagent qualification
  • Experience in problem solving (facilitation and application of tools)
  • Basic statistical knowledge and experience with data analysis
  • knowledge about regulatory requirements concerning analytical test methods and licenses
  • Six Sigma Greenbelt training would be beneficial but is not required
  • fluency in German and English (sufficient for international teleconference calls)
  • target-oriented teamplayer, problem solving skills
  • strategical and analytical thinking

 

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is €  2.393,52 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.


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