• Licence as pharmacist
  • Doctorate in pharmaceutical biochemistry ("Dr. phil. nat." at the Johann-Wolfgang-Goethe-University Frankfurt am Main, Germany)
  • Specialist for pharmaceutical analytics
  • Qualified Person according to EU legislation (e.g. according to § 15 of the German Drug Law)
  • More than 20 years experience in the area of pharmaceutical quality control and quality assurance in various companies with pharma production and API synthesis
  • Extensive industry practice as laboratory manager, head of QC and senior director for quality control and quality assurance department
  • Sound knowledge of pharmaceutical production in the fields of solid dosage forms, semisolid and liquid forms, sterile and aseptic technique, as well as in the special fields of lyophilisates, metered dose inhalers, powder inhalers and herbal drugs
  • Performance of many audits of API producers, packaging material suppliers and pharmaceutical contract manufacturers
  • Experienced in handling customer audits and inspections of German and international authorities, including several FDA inspections

The CV of Dr. Carl-Erich Bittes is readily available on request - please drop a short notice to


If you took up services of an external provider, don't forget to put a qualification certificate of the acting persons into your archive! Some inspectors may ask for it ...

To download the qualification certificate of Dr. Carl-Erich Bittes please click here!