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Name

Silke Litzinger

Function

Senior Consultant,
Qualified Person

Dr Silke Litzinger

   

Experience since 2010

  • PharmaKorell GmbH, DE-München
  • CSL Behring AG, CH-Bern

Qualifications

  • Ph.D. in Natural Sciences in Microbiology, Universität Konstanz, DE-Konstanz
  • M.Sc. in Biology, Universität Konstanz, DE-Konstanz

Experience so far

Team Leader Microbiology (Sterility Testing, Identification of Microorganisms); Deputy Head of Microbiological Quality Control; Investigation of OOX-results and deviations; Change Control; CAPAs; Evaluation, Development and Validation of microbiological/biological analysis procedures (Sterility Test, TAMC, Germ-ID, Endotoxin Test); Microbiological professional management of projects (Set-up Sterility Test Laboratory clean room class D, (re-)qualification and validation of analysis devices); Microbiological Risk Assessments; Project Work (StarLIMS, Data Integrity); Lean Six Sigma Green Belt