Andreas Herrnsdorf
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Andreas Herrnsdorf
- 4 years and 3 months, Mar 2015 - May 2019Abbott in Deutschland
Project Manager, Division Quality Engineering
Inspection Readiness, Global, FDA, CBER,
- 3 years and 2 months, Jan 2012 - Feb 2015
MANAGER VALIDATION/QUALIFICATION
Abbott GmbH &Co KG
“PM Site Validation Master Plan”, “Software Quality Assurance (SQA)” - Support Validation/Qualification FUE, Software Life Cycle-SLC), Cleaning, PV, TMV, Division Global Process Community for Validation, FDA Inspection Readiness, Validation Subject Matter Expert in FDA and Corporate Audit, CBER Readiness Activities
- 7 years, Jan 2005 - Dec 2011
ASSISTANT MANAGER VALIDATION/QUALIFICATION
Abbott GmbH &Co KG
“PM Site Validation Master Plan”, “Software Quality Assurance (SQA)” - Support Validation/Qualification FUE, Software Life Cycle-SLC), Cleaning, PV, TMV, Division Global Process Community for Validation, FDA Inspection Readiness, Validation Subject Matter Expert in FDA and Corporate Audit, CBER Readiness Activities
- 1 year and 4 months, Oct 2003 - Jan 2005
SUPERVISOR VALIDATION/QUALIFICATION
Abbott GmbH &Co KG
“Head of Validation”, “Validation Quality Group (VQG)”, “PM Site Validation Master Plan”, “Software Quality Assurance (SQA)” - Support Validation/Qualification FUE, Software Life Cycle-SLC), Cleaning, PV, TMV
- 4 years and 3 months, Aug 1999 - Oct 2003
SUPERVISOR CALIBRATION/VALIDATION
Abbott GmbH &Co KG
Quality Systems and DNP Quality&Validation, “Calibration Coordinator”, “PM Site Validation Master Plan”, “Part11 Site Coordinator” - Maintained Control of Inspection, Measuring and Test equipment; Support Qualification FUE, Validation Non Product software, Cleaning Val., Manufacturing Process Val., Test Methods (TMV)
- 4 years, Sep 1995 - Aug 1999
SENIOR SPECIALIST III (CALIBRATION/VALIDATION)
Abbott GmbH &Co KG
“Calibration Coordinator”– Maintained Control of Inspection, Measuring and Test equipment;
- 1 year and 6 months, Apr 1994 - Sep 1995
CALIBRATION/VALIDATION SPECIALIST
Abbott GmbH &Co KG
Implemented and maintained Control of Inspection, Measuring and Test equipment; Qualification of Equipment, Facilities, Utilities (FUE); Cleaning Validation (CV)
- 10 months, Jul 1993 - Apr 1994
TECHNICIAN REPAIR SHOP
Abbott GmbH &Co KG
Abbott Instrument Swap (Repair) and Refurbishment, Refurb work flow improvement project
- 11 months, Sep 1992 - Jul 1993
TECHNICIAN QUALITY CONTROL
Abbott GmbH &Co KG
Instruments and Commodities – FSE training Abbott Instruments, QC tests on refurbished Instruments; First Article Inspections new and changed commodities; Incoming Control of Commodities
- 3 years, Sep 1987 - Aug 1990
RUNDFUNK-FERNSEHTECHNIKER GESELLE
Elektrohaus Lowin
Sprachen
German
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
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