Esra Arslan Ganiler

Tegernheim, Deutschland

Fähigkeiten und Kenntnisse

Analytical Performance Studies
Biotechnology
Food Science
Change Control
Gemba Kaizen
Microbiological tests
Complaint Investigations
Hygiene
Corrective and Preventive Action (CAPA)
Molecular Biology
In Vitro Diagnostics (IVD)
Design and Production of qPCR Kits
Molecular testing for food control
ISO 13485
Deviation Management
Product Development
ISO 17025
Document Management
Quality Control
ISO 9001
Food Safety
Quality Management
Master Control
Quality Management System
Method & Product Validation
R&D
Method validation
Root Cause Analysis
Real-Time PCR
TrackWise
Risk Analysis
Zendesk

Werdegang

Berufserfahrung von Esra Arslan Ganiler

  • 1 Jahr, Nov. 2024 - Okt. 2025

    Quality Engineer

    Thermo Fisher Scientific

    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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