Diana Mihova
Angestellt, RA/QA Specialist, Immucor Medizinische Diagnostik GmbH
Frankfurt Am Main, Deutschland
Werdegang
Berufserfahrung von Diana Mihova
Contribution to the quality assurance of IVD products according to ISO 13485, ISO 9001, IVDD, IVDR and cGMP standards. Initiation of Change Controls, Deviations, CAPAs. Performing Post market Surveillance, Risk Management, Market Authorization worldwide, Supplier evaluation and creation of Technical Documentation according to the (EU) 2017/746 IVDR. Evaluation of release testing according to the European Standards and performing product release. Support for internal and external audits.
7 Monate, Jan. 2020 - Juli 2020
Trainee Study-Start-Up and Regulatory
Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)
Submissions of clinical trials to ethics commitees (EC), competent authorities (CA) and local regulatory authorities (RA)
CRA - Hicher education course with emphasis on: GCP-Training GMP-Training Life Science Process- & Project Management Quality Assurance Quality Management Clinical Trial Management
3 Jahre und 7 Monate, März 2016 - Sep. 2019
Integrationsassistentin, Sprach- und Kulturmittlerin
MigraMundi e.V
Interpreter/Translator for non-German speaking Bulgarians, registered in various municipal institution, social facilities, political committees and organisations for migration
1 Jahr und 1 Monat, Okt. 2014 - Okt. 2015
Studentische Hilfskraft
Promerchant GmbH
Tutor in a practical course in neurobiology
Ausbildung von Diana Mihova
2 Jahre und 5 Monate, Okt. 2016 - Feb. 2019
Physical Biology of Cells and Cell Interactions
Goethe University Frankfurt
3 Jahre und 2 Monate, Okt. 2012 - Nov. 2015
Biowissenschaften
Goethe Universität Frankfurt
Sprachen
Deutsch
Fließend
Englisch
Fließend
Italienisch
Grundlagen
Russisch
Grundlagen