Klára Kostelanská
Quality Assurance Specialist at Fakultní nemocnice u sv. Anny v Brně (FNUSA) - St. Anne's University Hospital Brno / FNUSA-ICRC- Claim this Profile
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angličtina Full professional proficiency
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ruština Professional working proficiency
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italština Elementary proficiency
Topline Score
Bio
Credentials
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Pedagogika a)
Narodni Institut pro Dalsi Vzdelavani (NIDV) National Institute for Professional DevelopmentJun, 2019- Oct, 2024
Experience
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St. Anne's University Hospital Brno
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Czechia
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Hospitals and Health Care
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400 - 500 Employee
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Quality Assurance Specialist
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Jun 2021 - Present
- certificates for GCP, ISO 9001:2015 internal auditor, ISO 13485:2016, ISO 15189:2012, cGMP- experiences with internal audits- quality management for clinical research- controlled documentation (in Czech and English)- preparation for external audits- from March 2023 just QA Specialist for department Center for Clinical Studies - internal monitoring of clinical studies
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Professional Administrative Officer in the Quality Department
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Jan 2023 - Present
The Quality Management Department of the ICRC was merged with the Quality Management Department of FNUSA. Agenda maintained as for the position of Quality Assurance Specialist.- certificates for GCP, ISO 9001:2015 internal auditor, ISO 13485:2016, ISO 15189:2012, cGMP- internal audits - quality management for clinical research- controlled documentation (in Czech and English)- preparation for external audits
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Quality Manager for Center of Clinical Studies
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Mar 2022 - Present
Quality Manager for department of clinical studies.Responsibilities and authorities within ISO 9001.
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TestLine Clinical Diagnostics s.r.o.
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Czechia
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Biotechnology Research
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1 - 100 Employee
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Documentation technician
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Sep 2020 - May 2021
- technical documentation in Czech and English for in vitro diagnostics medical devices - prepare documents for registration to foreign countries - preparation for IVDR implementation - technical documentation in Czech and English for in vitro diagnostics medical devices - prepare documents for registration to foreign countries - preparation for IVDR implementation
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Queen's University Belfast
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United Kingdom
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Higher Education
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700 & Above Employee
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Visiting Researcher
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Sep 2019 - Dec 2019
- traineeship - undergo training for FTIR, UV/VIS, DSC, TGA, and XRPD - designed research project by own - presenting a project in English to scientists from around the world - traineeship - undergo training for FTIR, UV/VIS, DSC, TGA, and XRPD - designed research project by own - presenting a project in English to scientists from around the world
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University of Veterinary and Pharmaceutical Sciences (VFU Brno)
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Czechia
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Assistant
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Jan 2017 - Jun 2019
- work with the scanning electron microscope - operation and maintenance of laboratory equipment (such as SEM, UV/VIS spectrophotometer, laboratory centrifuge, tablet press, PharmaTest, moisture analyzer, laser diffraction, helium pycnometer, equipment for disintegration and friability of tablets) - project management, writing articles, and presenting the final project in front of an audience or expert committee - work with the scanning electron microscope - operation and maintenance of laboratory equipment (such as SEM, UV/VIS spectrophotometer, laboratory centrifuge, tablet press, PharmaTest, moisture analyzer, laser diffraction, helium pycnometer, equipment for disintegration and friability of tablets) - project management, writing articles, and presenting the final project in front of an audience or expert committee
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Education
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2014 - 2016
Univerzita Palackého v Olomouci
Master's degree, Material Chemistry -
2011 - 2014
Univerzita Palackého v Olomouci
Bachelor's degree, Management in Chemistry -
2016 -
Masarykova univerzita Brno
Doctor of Philosophy - PhD, Pharmaceutical Technology
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