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Name

Wiebke Hallensleben-Steen

Function

Senior Consultant,
Qualified Person,
Lead Auditor

Dr Wiebke Hallensleben-Steen

 

 

Experience since 1999

  • PharmaKorell GmbH, DE-Lörrach
  • Dr. Falk Pharma GmbH, DE-Freiburg
  • Biochip Technologies GmbH, DE-Freiburg

Qualifications

  • Ph.D. in Biology, Albert-Ludwigs-University Freiburg, DE-Freiburg
  • M.Sc. in Biology, Albert-Ludwigs-University Freiburg, DE-Freiburg

 

Experience so far

Senior Consultant; Lead-Auditor; Qualified Person (German Pharmaceutical Legislation); Project Management; Head of Quality Control; Deputy Head of Manufacturing; Deputy Head of Quality Assurance; Quality Assurance Manager GMP/GDP; Quality Management ISO 9001 and ISO 13485; Batch Record Review; Document Management; CAPA- and deviation management; Supplier qualification; GMP/GDP training; Quality agreements; Product quality reviews; Computer system validation; Inspection of international authorities; Development of gene expression analysis methods on microarrays