Dr. Gerhard Hartmann
Suchst Du einen anderen Gerhard Hartmann?
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Gerhard Hartmann
- Current 5 years and 11 months, since Jul 2020
QA & CSV Spezialist
Pharmazeutischer Hersteller
QA Spezialist in einem Projekt zur Automatisierung von Produktionsanlagen
- 3 years and 11 months, Aug 2017 - Jun 2021
Senior Validation Consultant
Biotech - Startup
Validation / Change Management of MES for production process for individualized pharmaceuticals (oncology)
- 7 months, Jan 2017 - Jul 2017
Senior Validation Consultant
Internationaler Hersteller von Medizinprodukten
SAP Validation Development / Optimization of CSV Strategy
- 1 year and 1 month, Dec 2015 - Dec 2016
Senior Validation Consultant, QA Manager
Medical Device Manufacturer
Introduction of CSV, Validation of computer systems in final process control
- 4 months, Apr 2016 - Jul 2016
GMP Senior Auditor
Blood Product Manufakturer
Audit of several suppliers (blood centers)
- 4 months, Dec 2015 - Mar 2016
Senior Validation Consultant
Laboratory Services Provider
Part 11 evaluation of a data capturing system
- 1 year, Jan 2015 - Dec 2015
Senior Validation Consultant
International Pharmaceutical Manufacturer (Germany)
SAP GRC - Validation Management - Change Management - Training - Test Management
- 7 months, Dec 2014 - Jun 2015
Senior Validation Consultant, QA Manager
Supplier for pharmaceutical industry (IT Solutions)
Introduction of a GMP compliant Quality Management System
- 4 months, Feb 2015 - May 2015
Senior Validation Consultant
Supplier for pharmaceutical industry (IT Solutions)
Design of a GMP compliant Quality Management System
- 3 months, Feb 2015 - Apr 2015
Senior Validation Consultant
Supplier for pharmaceutical industry (IT & Hardware Solutions)
GMP / Part 11 Compliance Audit
- 6 months, Jul 2014 - Dec 2014
Senior Quality Management Consultant
International Manufacturer of Analytical Systems (USA, German locations)
Introduction of a Quality Management System for Services provided to Pharmaceutical / Life Science clients
- 3 months, May 2014 - Jul 2014
Senior Validation Consultant
International Medical Device Manufacturer (Germany)
FDA Audit preparation for a microbiological laboratory
- 7 months, Jan 2014 - Jul 2014
Senior Validation Consultant
International Pharmaceutical Manufacturer (Germany)
SAP GRC / Solution Manager Change Management Training Test Management
- 9 years and 2 months, Nov 2004 - Dec 2013
Senior Validation Consultant, QA Manager
International Pharmaceutical Manufacturer (German)
Validation Design and Management of international SAP deployment: - Definition of validation strategy and methodology - Preparation of guidelines and trainings - Coordination of parallel deployments - Development of tools quality assurance and quality monitoring for the deployments - Conduction of validation activities in the deployments QA Manager Project Management / Validation of: • Requirement Management System • Audit Management System • Test Management System
- 3 years and 1 month, Jan 2009 - Jan 2012
Validation Consultant, Auditor
International Pharmaceutical Manufacturer (Japan), German facilities
SAP Re-Validation Mock Audits for IT systems
- 1 year and 2 months, Nov 2010 - Dec 2011
Validation Consultant, Auditor
International Medical Device Company, (US)
GMP Compliance Audit SAP Validation support
- 1 month, Nov 2011 - Nov 2011
QM Auditor
International Pharmaceutical Manufacturer (German)
GMP Compliance Audit
- 4 months, Dec 2010 - Mar 2011
QM Auditor
International Medical Device Company, (Switzerland)
IT FDA Compliance Audit
- 1 month, Jan 2011 - Jan 2011
QM Auditor
International Medical Device Company, (Germany)
IT FDA Compliance Audit
- 8 months, Apr 2007 - Nov 2007
Validation Consultant
National Medical Device Manufacturer (Germany)
Clean room production concept
Ausbildung von Gerhard Hartmann
- 1985 - 1989
Chemie
TH Darmstadt
- 1981 - 1984
Chemie
TH Darmstadt
Analytische Chemie, Chemische Technologie
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
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