Ing. Bernhard Brodowicz
Selbstständig, Senior Quality Assurance Consultant, Self Employed Freelancer
Abschluss: Master of Science, University of Salzburg
Basel, Schweiz
Über mich
With ten years of experience in quality assurance and validation, I am a senior QA consultant and the founder of my own company, providing quality systems and qualification/validation services to clients in the biotechnology and pharmaceutical industries. My mission is to ensure compliance with international GMP regulations and industry best practices, and to enable the successful implementation of new technologies and processes. My core competencies include equipment and computerized system validation, CAPA management, audits, risk analysis, IT systems implementation, and project management. I have a strong background in molecular biology, neurobiology, and electronics, and I have published multiple papers in peer-reviewed journals. I have also worked in multicultural and multidisciplinary teams, and I am fluent in German, English, and Spanish. I am passionate about delivering high-quality solutions that meet the needs and expectations of my clients and their stakeholders.
Werdegang
Berufserfahrung von Bernhard Brodowicz
Bis heute 2 Jahre und 11 Monate, seit Juli 2021
Senior Quality Assurance Consultant
Self Employed Freelancer
GMP | Pharmaceuticals | Medical Devices | CSV | Qualification | Validation | Audits
1 Jahr und 2 Monate, Nov. 2019 - Dez. 2020
Team Leader Metrology & Lab Ops
Sandoz
• Leaded the metrology team (2 Metrology Experts and 3 Lab Associates) including task delegation, defining priorities, staff development & training • Capacity planning and effectively ensuring the throughput of tasks within the metrology team • Providing metrology support to development project teams • Ensured timely implementation of new equipment • Managed the equipment lifecycle including calibrations, maintenance and changes • Ensured that process and timeline requirements for procurement are met
6 Monate, Mai 2019 - Okt. 2019
QA Manager Analytics & Stability
Sandoz
• Reviewed and approved analytical instrument qualifications, risk assessments and SOPs • Acted as eCompliance Manager for SDC Unterach • Tracked re-qualification and calibration tasks • Released reference standards • Reviewed logbooks and protocol books • Approved deviations, change controls and CAPAs related to analytical development • Conducted self-inspections and supported inspections by authorities
2 Jahre und 3 Monate, Feb. 2017 - Apr. 2019
QA Manager - Quality in Operations
Novartis
• Reviewed and approved method validations, stability protocols, instrument qualifications • Acted as eCompliance Manager for IT, Production and QC Laboratory • Reviewed and approved process and cleaning validations, risk assessments, APQRs, equipment qualifications, change requests, CAPAs and SOPs • Supported GxP-activities on PFS production-line to ensure department and production goals are met and performed QA-oversight activities on the shop floor to ensure audit readiness
3 Jahre und 1 Monat, Jan. 2014 - Jan. 2017
Quality Assurance Manager and Quality Control Manager
EVER Neuro Pharma GmbH• Planned and managed equipment qualification, method validation and transfer projects • Reviewed and approved method developments , experimental designs and investigations as well as risk analysis, qualifications and validations • Performed internal and external audits and actively contributed to inspections by authorities
2 Jahre und 2 Monate, Aug. 2011 - Sep. 2013
Research Associate in the Group for Receptor Biochemistry and Tumor Metabolism
Paracelsus Medizinische Privatuniversität• Cultivated and stimulated human tumor cell lines • Extracted, separated and stimulated human leukocytes • Diagnosed GPCR expression and responses via qRT‐PCR, Western blot analysis, flow cytometric analysis (FACS), ELISA, proliferation and cytotoxicity assays and Label‐free diagnosis • Supervised interns and master students Achievements: Discovered galanin receptor expression on human immune and tumor cells and detected cell responses to galanin receptor agonists and antagonists
1 Jahr und 5 Monate, März 2010 - Juli 2011
Master student in the Group for Receptor Biochemistry and Tumor Metabolism
Paracelsus Medizinische Privatuniversität• Cultivated human tumor cell lines • Analysed GPCR expression via qRT‐PCR • Histologically detected receptors on cells and tissues Achievements • Demonstrated subtype specificity for human anti‐galanin receptor antibodies for the first time • Illustrated for the first time and in detail the cellular expression and localization of the galanin
3 Monate, Juli 2008 - Sep. 2008
Internship in the Research Group for Molecular Ecology
Austrian Academy of Sciences
• Performed computer-aided differentiation of toxic cyanobacteria • Conducted multilocus sequence typing of the cyanobacterium Planktothrix spp. • Quantified the net production of the toxic microcystine via HPLC and mass spectrometry
5 Jahre, Okt. 2001 - Sep. 2006
Military service with UN-overseas mission in Syria/Israel (Golan Heights)
Austrian Armed Forces
• Instructed recruits and trained peacekeepers for foreign operations • Managed the office of the company and maintained the complete IT-infrastructure on base
Ausbildung von Bernhard Brodowicz
Bis heute 9 Jahre und 8 Monate, seit Okt. 2014
Law, distance learning program
Johannes Kepler University Linz
2 Jahre, März 2010 - Feb. 2012
Genetics specialized in Molecular Biology
University of Salzburg
Graduated with distinction Thesis: ‘Evaluation of galanin receptor antibodies in normal and pathologic tissues’
3 Jahre und 5 Monate, Okt. 2006 - Feb. 2010
Genetics specialized in Molecular Biology
University of Salzburg
Thesis': ‘Ribosomal associated diseases’ and ‘Recombineering in DNA cloning’
4 Jahre und 10 Monate, Sep. 1996 - Juni 2001
Electronics specialized in Technical Computer Science
HTBLA Salzburg
Thesis: ‘Embedded-LAN/Time Recording Device’
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Spanisch
Gut