
Esra Arslan Ganiler
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Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Esra Arslan Ganiler
Main Tasks: • Management of quality management system documents, • Management of the change control process, • Evaluation and classification/ranking of customer complaints, • Identification and assessment of nonconforming materials and deviations, • Management of deviations, CAPAs, and root cause analysis.
- 2 Jahre und 9 Monate, Mai 2021 - Jan. 2024
Regulatory Affairs and Quality Manager
BioeXsen GmbH
Main Tasks: • Management of quality management documents in accordance with ISO 13485, • Review of validation studies and preparation of technical documentation for IVD products (real-time PCR kits), • Management of FDA and WHO registration and approval procedures for in vitro diagnostic devices.
- 8 Monate, Sep. 2020 - Apr. 2021
Analysis Specialist
Krankenhaus Barmherzige Brüder
Main Tasks: • Performing nucleic acid extractions and PCR tests (COVID-19) on clinical samples.
- 2 Jahre und 9 Monate, Jan. 2018 - Sep. 2020
Regulatory Affairs and Quality Manager
Bioeksen R&D Technologies
Main Tasks: • Establishment and management of the quality management system in accordance with ISO 13485, • Management of quality management system documents, • Management of non-conformities and conducting Risk Analyses, • Management of deviations, CAPAs, and root cause analysis, • Registration of IVD products with the Ministry of Health system and other certifications.
- 2 Jahre und 9 Monate, Mai 2015 - Jan. 2018
Microbial Genetics R&D Supervisor
Bioeksen R&D Technologies
Main Tasks: • Research and development of molecular test methods for food and water safety, • Research and development of nucleic acid-based test methods for the detection of viral and bacterial animal disease agents, • Production of nucleic acid extraction kits and real-time PCR kits, • Product validations, • User training (on-site) and field applications.
- 1 Jahr und 4 Monate, Okt. 2009 - Jan. 2011
Analysis Specialist
A&T Food Control Laboratory
Main Tasks: • Conducting microbiological analyses of food samples, as well as researching and developing new methods for detecting and identifying microorganisms in food, • Conducting PCR tests to detect GMOs, allergens, and meat types in food samples and developing new analytical methods.
- 2 Jahre und 9 Monate, Jan. 2006 - Sep. 2008
Responsible Manager
CARREFOUR - Dilem Food Industry and Commerce Limited Company
Department of Bakery & Pastry Products - Main Tasks: • Monitoring of workplace conditions, the production process, and personal hygiene.
- 2 Monate, Juli 2003 - Aug. 2003
Trainee
UNILEVER Industry and Commerce Corporation, Corlu
Department of Margarine Production: Learning technology of margarine production. Department of Ketchup & Mayonnaise Production (Calvé): Following manufacturing steps of ketchup and mayonnaise. Laboratory of Quality Control Analysis: Learning chemical and physical analyses of margarine, ketchup and mayonnaise. Laboratory of Microbiology: Learning to carry out microbiological analyses.
Ausbildung von Esra Arslan Ganiler
- 2007 - 2008
Master's degree
Università degli Studi di Salerno
(Erasmus Program)
- 2 Jahre und 11 Monate, Sep. 2005 - Juli 2008
Master's degree
Çanakkale Onsekiz Mart Üniversitesi
- 2001 - 2005
Bachelor's degree
Çanakkale Onsekiz Mart Üniversitesi
Sprachen
Türkçe
C2 (Verhandlungssicher / Muttersprachlich)
İngilizce
B1-B2 (Gute Kenntnisse)
İspanyolca
A1-A2 (Grundkenntnisse)
Almanca
B1-B2 (Gute Kenntnisse)
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