Lucie Flajsarova

An engineer with 13 years' experience in pharmaceutical industry, graduated from the VŠB-Technical University of Ostrava, where she studied Environmental Engineering. She implemented the environmental management system in PLIVA-Lachema, then the quality system in the Diagnostics Division. In the year 2003 she started work at the Pharmacy Division as GMP Inspector, then she worked as Qualification & Validation Specialist (equipment, HVAC systems, media, process and product validations, cleaning validations). From the viewpoint of compliance with GMP and EU/US legislation and regulations she was in the team for selection and installation of an isolator line for CTS injections.

She completed her work in PLIVA - Lachema a.s. as the Qualified Person for releasing of medicinal products and Quality Specialist (Quality System according to EU/US requirements, regulatory affairs and solutions of deficiencies, risk analysis, GMP audits, consulting and training). In the mentioned period, she continuously participated in trainings in the field of GMP in aseptic manufacturing and quality assurance and in process validations. She participated in several ECA trainings abroad in the fields of qualification/validation, cleaning validation, management of validations, media fill, isolators, etc. During inspections (SÚKL, FDA, customers) she was responsible for some parts of the quality system (documentation, change management, deviations, qualification/validation etc.).

In 2010 she became a co-founder of Pharm Partners, where she is responsible for the compliance of projects with current GMP requirements, for auditing, consulting and training. She participates in training courses abroad (isolator technologies, RABS, etc.) to meet all the current requirements as early as the design phase of pharmaceutical plants and to prevent unnecessary budget increase and subsequent loading of routine production with operating costs.

Simultaneously, she occupies the position of Quality Manager and Qualified Person for the Faculty of Medicine, Masaryk University in Brno.