Melanie B. Wagner

Quality assurance professional with 8+ years of experience in internationally operating companies for a broad range of pharmaceutical dosage forms and product types. Key focus on bringing stakeholders together to achieve short- and long-term quality expectations and lead in quality projects and processes. 

Balancing meticulous attention to detail with overarching strategic goals, I initiate and drive the
integration of quality into the fabric of company culture as a means to streamline resources. My professional journey is driven by the delivery of safe, high-impact pharmaceutical products for patients and customers alike, grounded in sustainable, pragmatic and forward-thinking practices.

Central Work experience 

• 7+ years GMP work experience
• 5 years QA/QS manager experience
• cGMP (CFR 21), EU GMP (Eudralex), PMDA (Japan)
• Process Owner / Lead
• DEV/CAPA/CR (operational and global)
  (e)QMS development
• Work Lifecycle / Staff Qualification
• Root Cause Analysis /Investigational Excellence Training e.g.: 5 Whys / Fault Tree / Ishikawa Diagram (Fishbone) / 5M / Pareto Principle
• Risk Assessments (e.g. FMEA)
• DIN EN ISO 9001 QMR-TÜV
  (Quality Management Representative,
  German: QMB-TÜV)

Pharma-Expertise-Keywords

• Parenteral, oral, topic, ophthalmic product
• Liquids, powder, solids, semi-solids, vials, ampoules, blisters, tubes, oral solid dosage (OSD)
• Regulated substances, high-potency API
• Investigational Medicinal Products (IMP), Live biotherapeutic products (LBP)
• Sterile and aseptic production 
• RABS/Isolator, Single-Use Systems
• Fill-Finish, serialisation, in-line packaging
• DS and DP
• Phase I-III, commercial GMP

IT Tools

• TrackWise Digital (QMS) / Trackwise Sentry (QMS)
• Stand alone Documentum (easyDoc, Archive / EMC2 Life Science Solutions D2)
• Microsoft Office: Word, Excel, Power Point, Sharepoint, Teams
• Microsoft Visio
• SAP

Languages

• German (native language)
• English (native level)
• French (good conversational)

Doctor of Philosophy (PhD; Doctorate) 
(Molecular plant pathology, Wagga Wagga / Canberra, Australia)

Biotechnology Diploma 
(Tri-national double degree, Université de Strasbourg (UdS), France; Albert-Ludwigs-Universität Freiburg, Germany, Karlsruhe Institute of Technology, Germany and University of Basel, Switzerland)

Master of Pharmaceutical Sciences
(Université de Strasbourg (UdS), Strasbourg, France, Faculté de Pharmacie (Faculty of Pharmacy), Illkirch, France)