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Fabian Baiz

Angestellt, QA Key Person Process Validation, Vetter Pharma
Biberach an der Riß, Germany

Skills

Qualitätsmanagement
cGMP
Aspetic Handling
Ausbildung im Bereich Pharmazie/Biotechnologie
Raman-Mikroskopie
Kommunikationsfähigkeit
Kontaktfreudigkeit
Teamfähigkeit
Loyalität
Aufgeschlossenheit
Zuverlässigkeit
kreative Lösungen
Anpassungsfähigkeit
Computerkenntnisse
Menschenkenntnis
Raman-Spektroskopie
Networking
EndNote
Mac OS X

Timeline

Professional experience for Fabian Baiz

  • Current 2 years and 2 months, since Apr 2023

    QA Key Person Process Validation

    Vetter Pharma
  • 3 years and 1 month, Mar 2020 - Mar 2023

    Quality Assurance Consultant

    FERCHAU

    Quality Assurance Consultant in Development (NCE/NBE) at Boehringer Ingelheim Pharma GmbH & Co. KG on behalf of FERCHAU GmbH (Ulm, Germany) - QA für Equipment Qualifizierung in der analytischen Entwicklung - Review und Freigabe von LeVA Dokumenten - Key User & Quality Approver für TrackWise GoTrack (Change Control) - Review & QA-Freigabe von technischen Änderungen (Change Control) in der analytischen Entwicklung - Review & QA Freigabe von Kalibriervorgabelisten (KVLs) - Review von SOPs & Betriebskonzepten

  • 11 months, May 2019 - Mar 2020

    Production Technican/Associate for Gene Therapie

    Kiadis Pharma

    Structure, Development and Establishment of an aseptic ATMP Production site under GMP conditions in cooperation with PD, QA and QC in clean room conditions (class A/B) - Implementation & optimization of a production process - Writing, revision and optimization of GMP documents - Support in the investigation of quality defects - Responsible for equipment, calibration/maintenance and qualification (FMEA, DQ, IOQ, PQ) - Part of the quality assurance system (deviation management, CAPA, Change Control)

  • 1 year and 7 months, Sep 2017 - Mar 2019

    Technical Assistent

    Boehringer Ingelheim

    - Method development & establishment for spectroscopic imaging incl. development of suitable preparation techniques for biological material - Establishment/development of imaging and spectroscopic methods for specific diagnostics and correlative analysis methods (RAMAN, MALDI Imaging, light/fluorescence microscopy, electron microscopy) - Investigation and characterization of particles via scanning electron microscopy and elemental analysis - Studies under GMP/GLP conditions

  • 3 months, Jun 2017 - Aug 2017

    Research Assistant

    Boehringer Ingelheim

    - Method development & establishment for spectroscopic imaging incl. development of suitable preparation techniques for biological material - Establishment/development of imaging and spectroscopic methods for specific diagnostics and correlative analysis methods (RAMAN, MALDI Imaging, light/fluorescence microscopy, electron microscopy) - Investigation and characterization of particles via scanning electron microscopy and elemental analysis - Studies under GMP/GLP conditions

  • 3 months, Mar 2017 - May 2017

    Bachelor Thesis

    Boehringer Ingelheim

    Department/Group: Analytical Development/Analytical Technologies, Nonclinical Drug Safety/Pathology Title of the thesis: Application of Raman spectroscopy in drug development Methods: Raman spectroscopy, IR spectroscopy, light microscopy, filtration, design of experiments, data analysis

  • 6 months, Sep 2016 - Feb 2017

    Internship Semester

    Boehringer Ingelheim

    Department/Group: Analytical Development/Analytical Technologies, Nonclinical Drug Safety/Pathology, Analytical Development Biologics/Services & Infrastructures Title: Establishment of Confocal Raman Spectroscopy for Pharmaceutical Development Methods: Raman spectroscopy, light microscopy, design of experiments, data analysis

  • 1 year and 10 months, Nov 2014 - Aug 2016

    Working Student

    Boehringer Ingelheim

    * 20% Employment - Creation of a scientific database for the compilation of dossier documents (EndNote) o Creation of the database from literature o Optimization/adjustment of the program (document code and quality attributes) o Literature research - Creation of a database to manage product-specific reports - Creation of graphics (in Origin) for the creation of approval documents - Revision of specific approval documents with a view to language, content, references and formatting

Educational background for Fabian Baiz

  • 2 years and 1 month, Sep 2018 - Sep 2020

    Biopharmaceutial/Medical-Technical Sciences (M.Sc.)

    Hochschule Biberach - Biberach University of Applied Sciences/University Ulm

    - part-time master's programme - 70 % of the theoretical modules have already been successfully completed

  • 4 years, Sep 2013 - Aug 2017

    Pharmaceutical Biotechnology

    Hochschule Biberach - Biberach University of Applied Sciences

    Chemistry, mathematics/statistics, physics, bioinformatics, biotechnology, biochemistry, physiology, cell biology, microbiology, molecular biology, genetic engineering, cell culture technology, protein biochemistry, process engineering, sterile and clean room technology, GMP, protein analysis

  • 2 years and 11 months, Sep 2009 - Jul 2012

    Pharmazie/Biotechnologie

    Apprentice: Pharmaceutical Technician

    Training to become a pharmaceutical technican (skilled worker) which is certified by the Chamber of Industry and Commerce. Training assignments outside the training were completed in Validation & Qualification, Biopharmaceutical Drug Production (USP & DSP) and Pharmaceutical Development.

Languages

  • German

    First language

  • English

    Fluent

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