RNDr. Jan Břemek, senior consultant and auditor
Education:
Master degree 1981 at University Jan Evangelista Purkyne, Brno, Faculty of Science, subject: biology
RNDr. Degree at University J. E. Purkyne Brno– institute of microbiology, 1982
Postgraduate degree 1998 at IPVZ Praha (pharmaceutical technological processes)
MBA degree 2002 – Master Business Administration Programme, John Mores University Liverpool & Technical University Ostrava
Qualified person course at IPVZ Praha, 2009
Certified GMP trainer
Certified GMP Auditor
Certified ISO 9001 Auditor
Working experience:
Galena a.s., (hereafter IVAX Pharmaceuticals, s.r.o., now TEVA Czech Industries s.r.o.) on positions:
- Research Technologist of R&D Biotechnological Department 1983 – 1991(responsible for science/technological support and realization of biotechnological plant (submersion fermentation) incl. laboratory (author and co-author of patents and publications in biotechnology field)
- Head of API Production Department 1991 – 1995 (GMP principles implementing and receiving of GMP certificate for 15 APIs)
- Pharmaceutical Production Director 1995 – 2007 (GMP principles implementing and receiving of GMP certificate for product of Liquid, Solid and SGC forms)
GM. PROJECT, s. r. o. on positions:
- Head of Technology Development Department 2007 – 2009
- Head of Consulting Department 2009 – 2014
- Senior Scientific Consultant 2014 – 2016
Top GMP Consult
- senior consultant 2016 – present
Languages:
- czech
- english
- russian
Certificates:
Ing. Jan Veverka, IS/IT senior consultant
Education:
ČVUT Prague, branch Technival cybernetics, 1975 – 1980
Completed courses:
- English language, Worchester UK, 1991
- IIR Technology, IS/IT project management, 2002
- ITIL, bases of ITSM, 2005
- Management courses
- Gustav Käser training, Management 1, 1994
- CMC Čelákovice, Dynamic manager, 2000
- Internal – Improvement of middle management, 2007-8
- Internal GMP training
Working experience:
Galena a.s., (hereafter IVAX Pharmaceuticals, s.r.o., now TEVA Czech Industries s.r.o.) on positions:
- TEVA Czech Industries s.r.o. Opava – Project manager of IS/IT projects (2008-2014),
- ePedigree – serialization of production for US market and other selected markets
- OEE – Overall Effectiveness Efficiency in tablet packaging
- MES – Manufacture Execution System (2008-2012) for New OSD plant (tablets, capsules)
- IVAX Pharmaceuticals s.r.o., – IS/IT Director 1991-2008
- Leading IT department
- Responsibility for development and maintenance of IS/IT/ICT solution in the Czech Republic
- Management of significant IS/IT/ICT projects
Top GMP Consult
- IS/IT senior consultant 2017 – present
- Team leader for IT projects at TOPGMPConsult company
- Qualification of IS in pharmaceutical industry
- Trainings in the scope of Annex 15 EU GMP and Part 11 21 CFR
Languages:
- czech
- english