Fabian Baiz

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

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)

- 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

- 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

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

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

* 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

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

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

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.