Dipl.-Ing. Mike Wallenstein
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Mike Wallenstein
- Current 9 years and 1 month, since May 2017Novartis
Executive Director QA - Senior Compliance Officer
- 7 years, May 2010 - Apr 2017
Director QA / Global Senior Compliance Professional
Novartis Pharma AG
- Performing and documentation of regulatory compliance assessments. - Review and approval of proposed corrective/preventative action plans. - Verification of implementation and effectiveness. - Performing site risk assessments, identifying critical control points, determine effectiveness of related remediation activities and providing on-going project support and governance. - Performing of pre-approval/pre-submission projects - Site preparation for key Health Autority Inspections - Trainer
- 2 years and 6 months, Nov 2007 - Apr 2010
Manager Global Audit Systems
Gambro Dialysatoren GmbH
Senior Manager for Quality Audits related to global Medical & Pharmarceutical requirements. - Administration and Coordination of global internal Auditors - Corporate Lead Auditor for internal and Supplier audits - Planning, execting and reporting of corporate audits - Managing of global improvement projects - Managing of 3rd party-, customer audits and legal inspections. (e.g. FDA) - Supervision
- 5 years and 1 month, Oct 2002 - Oct 2007
Leader Quality Management System & European Audit Unit
3M Medica
- European responsibility for Implementation and maintenance of a QMSy according ISO 9001, ISO 13485, CMDCAS and FDA QSR for Medical Devices & Pharmaceuticals - Preparation and moderation of global management review meetings - Implementation and maintenance of an audit system for internal and supplier audits - Lead Auditor Medical & Pharmaceuticals Europe - Global audit experience - Six Sigma Green Belt - Employee supervision - Trainer for QM, MDD, (c)GMP, GLP, GPP, GDP...
- 6 years and 5 months, May 1996 - Sep 2002
Project Manager
PFEiWA-Consulting & Ingenieurbüro GmbH – Bottrop/Germany
- Responsible for implementation and maintenance of Quality Management Systems of medical device manufacturer and hospitals - Familiar with all methods of a modern quality management like CQA, SPC, FMEA and others - Preparation, execution and consulting on internal and external audits. - Leading training groups for DIN EN ISO 9000ff and DIN EN ISO 46001 as trainer. - Participation on many trainings related to Quality Management - Trained Auditor
- 6 months, Nov 1995 - Apr 1996
Project engineer
DuRec Recycling GmbH – Duisburg/Germany
Logistic, materials control, machine technology and staff placement (04/96 bankruptcy)
- 7 years, Sep 1983 - Aug 1990
Technician
Hoechst AG, Werk Ruhrchemie – Oberhausen/Germany
Technician for plastic technologies in research and development for Ultra High Molecular Polyethylene
Ausbildung von Mike Wallenstein
- 4 years and 2 months, Sep 1991 - Oct 1995
Chemical Engineering
Münster
Plastic Technologies
Sprachen
English
German
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