Mag. Gabriela Schallmeiner, QP

INSPECTION-READY Quality Consulting

Owner, Freelance Quality Compliance Consultant

Gabriela is an appointed Qualified Person according to the European regulations and has acted as such in the EU for 10+ years. She has held different managing positions in (Bio-)Pharmaceutical and Medical Devices industry and other related areas.

She is a stated expert in quality systems and compliance for GLP, GMP, GDP, and ISO13485. She provides assistance in setup and maintenance of client-tailored quality systems for commercial and investigational medicinal products and for medical devices/IVD.

In January 2007, Gabriela founded her own company INSPECTION-READY Quality Consulting.
She is a foundation member and deputy chairwoman of the Austrian QP Association (www.austria-qp.at).

Experience (selection)

  • 2007 to date: Owner of and Senior Expert Consultant at INSPECTION READY Quality Consulting, Austria.
  • 2010 to 2016: Head of QA, Head of QC, Head of External Manufacture, RA support and Qualified Person at AFFiRiS AG, Austria
  • 2007 to 03/2011: Area QA and Compliance Manager in 35+ countries for Consumer Healthcare at Whitehall Export (now part of Pfizer) and Pfizer Consumer Healthcare, Austria
  • 06/2002 to 2006: Head of Quality Management, Qualified Person, Dep. Head of QC (full-time), and Global QA System Coordinator at Igeneon GmbH, Austria, since 2005 part of Aphton Inc., USA
  • etc.

Education

  • Mag. rer. nat. (=M.Sc.) in Microbiology with distinction at the University of Vienna, Austria
  • Participated in several partial studies in biotechnology/microbiology and pharmacy at various universities and departments in Vienna, Austria

Milestones and Achievements

  • Since 2009: Qualified Person in Germany
  • 2007: Founding of INSPECTION READY Quality Consulting
  • Since 2007: Founding member and deputy chairwoman of Austrian Qualified Person Association
  • Since 2003: Head of QC (Kontrollleiter) and Qualified Person in Austria
  • 2007-2009: Responsible Person acc. to Austrian AMBO §10, equivalent to 2.2. of the EU GDP Guideline
  • 1994-1998: Non-restricted individual animal testing permission holder in Upper Austria