Ralf Dubielzig

QA / QP

Greater Munich Metropolitan Area

About

Pharmazeutische Industrie, Sachkundige Person, Qualitätssicherung, Marktprodukte sowie Prüfpräparate, GMP bzgl. Parenteralia, Salben und Tabletten, Wirkstoffe, Excipients; Audits von Lieferanten, Auftragsherstellern und -laboren weltweit (Europa, USA , Asien); Selbstinspektionen; Validierung, Stabilitätsuntersuchungen,Verantwortungsabgrenzungsverträge Pharmaceutical Industry, Qualified Person, Quality Assurance, commercial products and IMPs, GMP concerning parenterals, ointments, tablets, drug substances, excipients; audits of suppliers, contract manufacturers and laboratories worldwide (Europe, USA, Asia); self inspections, validation, stability studies, quality agreements

Experience

  • Otsuka Novel Products GmbH (Full-time · 13 yrs 1 mo)
    • Director Technical Operations / Qualified Person
      Mar 2022 - Present · 4 yrs 5 mos

      Coordination and management of cross-functional activities CMC projects, e.g. process /method transfers, changes Technical Agreements, audits

    • Associate Director QM / Qualified Person
      Jul 2013 - May 2024 · 10 yrs 11 mos

  • Medigene AG (10 yrs)
    • Director QA / Qualified Person
      Oct 2010 - Jun 2013 · 2 yrs 9 mos

      QP seit September 2012

    • Quality Assurance
      Oct 2004 - Sep 2010 · 6 yrs

      Associate Director (01/2010 - 09/2010) Senior Manager (02/2007 - 12/2009) Manager (10/2004 - 01/2007)

    • Senior Scientist Quality Control and Assay Development
      Jul 2003 - Sep 2004 · 1 yr 3 mos