Ing. Bernhard Brodowicz

Selbstständig, Senior Quality Assurance Consultant, Self Employed Freelancer

Abschluss: Master of Science, University of Salzburg

Weil am Rhein, Germany

About me

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.

Skills

Qualitätskontrolle
Qualitätsmanagement
Qualitätssicherung / Qualitätskontrolle
Validierung von Analysenmethoden
Qualifizierung von Anlagen
Qualitätssicherung
Qualitätssicherung von Software
FDA Regulation
cGMP Requirements
ISO 13485
Erfolg
Pharmaindustrie
Pharma
IT Validierung
CAPA Management
Methodenentwicklung
HLRA
Risikoanalysen
Risikomanagement
Deviation Management
Change Management
Qualitätsmanager
ERP
Produktion
Quality Assurance
Menschen
Messtechnik
Teamleitung
Personalentwicklung
Polymerasekettenreaktion
Training
MS Office
Deutsch
Englische Sprache
IT Documentation
Supplier Evaluation
Technical Documentation
Communication
Computer System Validation
Analytical Method Development
Regulatory Compliance
Computerized Systems
Quality Control Management
Laboratory Quality Assurance
Quality Assurance Processes
Data Analysis
Project Management
Computerized System Validation (CSV)
Consulting
Audit
FMEA
QMS
GxP
CSV
Excel Spreadsheet Validation

Timeline

Professional experience for Bernhard Brodowicz

  • Current 3 years and 1 month, since Jul 2021

    Senior Quality Assurance Consultant

    Self Employed Freelancer

    GMP | Pharmaceuticals | Medical Devices | CSV | Qualification | Validation | Audits

  • 1 year and 2 months, Nov 2019 - Dec 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 months, May 2019 - Oct 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 years and 3 months, 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 years and 1 month, 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 years and 2 months, 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 year and 5 months, Mar 2010 - Jul 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 months, Jul 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 years, Oct 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

Educational background for Bernhard Brodowicz

  • Current 9 years and 10 months, since Oct 2014

    Law, distance learning program

    Johannes Kepler University Linz

  • 2 years, Mar 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 years and 5 months, Oct 2006 - Feb 2010

    Genetics specialized in Molecular Biology

    University of Salzburg

    Thesis': ‘Ribosomal associated diseases’ and ‘Recombineering in DNA cloning’

  • 4 years and 10 months, Sep 1996 - Jun 2001

    Electronics specialized in Technical Computer Science

    HTBLA Salzburg

    Thesis: ‘Embedded-LAN/Time Recording Device’

Languages

  • German

    First language

  • English

    Fluent

  • Spanish

    Intermediate

Interests

Fotografie
Bergsteigen und Segeln
Nahm an verschiedenen Lauf‐ und Marsch‐Wettbewerben teil
Reisen und neue Länder und Kulturen erkunden

Browse over 21 million XING members