Monika Brazda M.Sc.

Senior Consultant and Partner

Monika is a diligent and reliable planning person whose vision is to increase GMP compliance, and, thus, improve the overall quality of products and workflows in (bio)pharmaceutical industry.

As a GMP expert, she knows the differences and similarities of various major regulatory guidelines and applies this knowledge into practice. That is, for qualifications as well as for designing and optimizing quality systems.

Her specialty is to understand the varying needs in GMP for QBDC’s clients, knowing that a small startup faces different challenges than big pharma. In close collaboration with the client, she finds the optimal solution, whether it be modifying an existing system to become GMP-ready or optimizing GMP workflows, or even designing and applying a new and fully qualified QMS from scratch.

Experience

  • 2018 to date: Partner at QBDC GmbH in Nusshof, Switzerland
  • 2013–2017: 2 years Head Engineering Compliance at Triplan Ingenieur AG, one of Switzerland’s leading providers of engineering services to the chemical and life science industries
  • 2008–2010: Head QC/QA at Celonic AG, a leading CDMO in Europe
  • 2006: Quality Manager at Greenhills Biotechnology, an Austrian Startup developing Influenza H9N1 Vaccine
  • 2001–2004: Qualification Engineer at LSMW-Vienna in several biotech construction projects
  • 2000–2001: Application developer for continuous chromatography at Prior Separation Technology

Education

  • M.Sc. in Biotechnology, focus on green biotechnology