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Name

Claus-Jürgen Koch

Function

Senior Consultant;
Qualified Person

Dr Claus-Jürgen Koch

   

Experience since 2002

  • PharmaKorell GmbH, DE-München
  • Luye Pharma AG, DE-Miesbach
  • Verla-Pharm Arzneimittel GmbH, DE-Tutzing

Qualifications

  • Pharmaceutical Quality Management, Universität Wien, AT-Wien
  • M.Sc. in Business Chemistry, FernUniversität Hagen, DE-Hagen
  • Ph.D. in Pharmaceutical Chemistry, Ludwig-Maximilians-University Munich, DE-München
  • M.Sc. in Chemistry, Ludwig-Maximilians-University München, DE-München

Experience so far

Qualified Person (German Pharmaceutical Legislation) für marketed products and IMPs; responsible person for narcotic drugs (German Narcotic Drugs Act); transdermal therapeutic systems; team lead; project lead; Quality Assurance; GMP-compliance, batch-record-review; CAPA- and deviation management; complaint mangement; management of Change Control procedures; investigations; training; risk management, Product Quality Reviews; customer audits and inspections of health authorities; supplier qualification (auditing); Head of Quality Control; quality control of starting materials, intermediates/bulk and finished dosage forms (incl. testing of packaging materials and microbiologic investigations); stability studies; validations