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Name

Stefanie Schmidt

Function

Senior Consultant

Dr Stefanie Schmidt

   

Experience since 2010

  • PharmaKorell GmbH, DE-München
  • Wasserburger Arzneimittelwerk GmbH, DE-Wasserburg a. Inn
  • Temmler Werke GmbH, DE-München
  • Haupt Pharma GmbH, DE-Wolfratshausen

Qualifications

  • Expert Pharmacist for Pharmaceutical Analysis, Chamber of Pharmacists in Lower Saxony, DE-Hannover
  • Ph.D. in Natural Sciences, Technical University Braunschweig, DE-Braunschweig
  • Pharmacist, Technical University Braunschweig, DE-Braunschweig
Experience so far
Qualified Person (German Drug Law); Quality Assurance; Head of Production; Contract Manufacturing; Manufacture and Testing of Sterile Liquid and Lyophilized Medicinal Products (Aseptic Filling, Terminal Sterilization, Visual Inspection, Packaging); Manufacture of Solid and Liquid Medicinal Products; Batch-Record-Review; CAPA-, Deviation- and Complaint Management; Change-Control; Product Quality Review; Quality Agreements; Preparation of Master Manufacturing and Packaging Instructions; Transfer of Products and Equipment; Process Validation; Training; Continuous Improvement Process; Audits and Inspections