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Gunter Barbosa-Friedrich

ist verfügbar. ✅

Self-employed, Senior Validation Consultant, Self employed contractor

Until 1991, Chemieingenieurwesen, Fachhochschule für Wirtschaft und Technik Reutlingen

Valencia, Spain

Skills

Computer System Validation (CSV)
FDA-Compliance
GMP
Validierung
GMP Compliance
21 CFR 820
21CFR Part 210
21 CFR Part 211
21 CFR Part 11
ISO 14791
Risk Management
Risikoanalyse
ISO 13485
Medical Devices
Medizintechnik
Datenschutz
Datensicherheit
Audits
Compliance Management
Qualitätssicherung
Quaility Assurance
EU-GMP
ERP
LIMS
LIMS Validierung
CAPA
FDA
FDA Inspektionsvorbereitung
Audit
Pharma
Life & Science
Health Care
Prozessberatung
Computervalidierung
Projektmanagement
Training
Coaching
Prozesse
ITIL 4

Timeline

Professional experience for Gunter Barbosa-Friedrich

  • Current , since Oct 2014

    Senior Validation Consultant

    Self employed contractor

    Validation of computerized system Quality Assurance / eCompliance Authoring of SOP for SDLC

  • 2 years and 4 months, Jun 2012 - Sep 2014

    Senior Validation Consultant

    NNE Pharmaplan

    Change Management, CAPA, Configuration Management, Computer System Validation, Equipment Qualification Project Lead of Automation Qualification project (construction of new building)

  • 1 year and 4 months, Feb 2011 - May 2012

    Service Manager

    HGP AG

    Organization of the transfer of a help desk from India to Switzerland. 1st Level support for MES 2nd Level Support for Labeling System

  • 8 months, Jun 2010 - Jan 2011

    Senior Validation Consultant

    Liance GmbH

    Vnalidation of computerized systems (Novartis)

  • 1 year and 2 months, Apr 2009 - May 2010

    Validation Consultant

    Self Employed Freelancer

    Process Validation (Novartis, Marburg): Mainly elimination of documentation gaps which have been detected during an external audit

  • 8 months, Aug 2008 - Mar 2009

    Senior Validation Consultant

    Livec GmbH Lörrach

    Computer System Validation of data bases and computerized systems für Sanofi Pasteur MSD und Roche Diagnostics Deutschland GmbH

  • 1 year and 9 months, Nov 2006 - Jul 2008

    Validation Engineer

    Roche Diagnostics Deutschland GmbH, Mannheim

    • Process Validation Provision of service for process validation including creation of risk assessments, statistical evaluation of raw data and authoring of validation reports. Member of QA-Team responsible for Computer System Validation

  • 3 years and 4 months, Jul 2003 - Oct 2006

    Validation Consultant

    Self employed

    Computer system validation / Equipment Qualification Validation and Qualification projects for companies like - Rockwell Automation (MES division) - Pfizer - Roche (F) - Novartis - CeramTec - DOT Rostock

  • 2 years and 8 months, Jan 2001 - Aug 2003

    Validierungsingenieur

    Rockwell Automation

    Leitung und Durchführung nationaler und internationaler Validierungsprojekte von MES (Manufacturing Execution System)

Educational background for Gunter Barbosa-Friedrich

  • 4 years and 3 months, Apr 1995 - Jun 1999

    Betriebswirtschaft

    AKAD - Lahr

    Wirtschaftsinformatik

  • 3 years, Oct 1988 - Sep 1991

    Chemieingenieurwesen

    Fachhochschule für Wirtschaft und Technik Reutlingen

    Analytische Chemie, Verfahrenstechnik

Languages

  • German

    First language

  • English

    Fluent

  • Portuguese

    Intermediate

  • Spanish

    Basic

Wants

Computer System Validation (CSV)
Pharma
Medical Devices

Interests

Reading
Travelling
Saxophone
Jazz

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