Project Overview
Internal inspections and supplier audits, subsidiary of global pharmaceutical company, Vienna, Austria
Quality Assurance and Quality Control, including Interim Management, small biopharmaceutical company, Bielefeld and Hamburg, Germany
Consumer Healthcare Products, project leader for optimisation, validation, and transfer of analytical methods to subcontractors (Switzerland, Argentina, Mexico), evaluation of process and analytical data for preparation and execution of process validations (soft gelatine capsules, caplets, syrups), support of process optimisation and troubleshooting, German subsidiary of global pharmaceutical company, near Frankfurt, Germany
Manufacturing Science & Technology Consumer Healthcare Products, performance of continuous process verifications (CPV), preparation and evaluation of stability studies, troubleshooting and optimisation of analytical methods, headquarters of a global pharmaceutical company, near Mainz, Germany
Preparation, support and follow-up of FDA inspection according 21CFR 210 and 211, medium-sized pharmaceutical company, near Nuremberg, Germany
Third Party Quality Manager Consumer Healthcare Products, product design reviews, evaluation of continuous process verifications, preparation and evaluation of stability studies, support of quality managers, headquarters of a global pharmaceutical company, near Mainz, Germany
Deputy Head Quality Assurance, supervision of generic drug manufacturers, supplier audits, optimisation of quality processes, medium-sized pharmaceutical company, Berlin, Germany
Implementation of GLP in existing GMP system incl. successful inspection by the authorities, small biopharmaceutical company, Bielefeld, Germany
Interim positions, e.g. Head of Quality Assurance, Head of Process Quality, evaluation and optimisation of quality processes, deviation, change and CAPA management, process and quality data evaluation, subsidiary of a medium-sized US biopharmaceutical company, near Duesseldorf, Germany
FDA inspections according 21CFR 210 and 211, mid-size bio-pharmaceutical company, near Kiel, Germany
FDA inspections according 21CFR 110 and 111, medium-sized pharmaceutical company, near Nuremberg, Germany
Lectures for students of Biotechnological Instrumentation Engineering, University of Applied Sciences, Bielefeld, Germany
Interim Manager Quality Management Systems, establishment and optimisation of processes and systems especially in the quality control unit, root cause analyses in production, medium-sized subsidiary of a global medical device and pharmaceutical company, near Osnabrueck, Germany
FDA inspection according 21CFR 210 and 211, medium-sized pharmaceutical company, near Nuremberg, Germany
Self-inspections and supplier qualification, medium-sized subsidiary of global pharmaceutical company, Munich, Germany
FDA remediation program, deviation and CAPA management, mid-sized subsidiary of a global pharmaceutical company, near Salzburg, Austria
Support in preparation of technical and marketing material, small sensor manufacturer, Dusseldorf, Germany
Permanent Position
Harmonisation of GMP quality assurance systems of several sites in Europe and USA
Reorganisation of the quality assurance system (quality control) from a combined GLP and GMP system to a pure GMP system
Extension of the GLP quality assurance system at a subsidiary (quality control in vivo) to include GMP, harmonisation of the system with headquarters
Participation in the merger with a competitor (viral clearance studies)
Establishment of a GMP quality assurance system for the biotechnological production of an active pharmaceutical ingredient at a subsidiary company.
Design and implementation of a validation system for computerized systems
Implementation of a quality assurance system at a supplier
Established stability storage facilities and system
Established and implemented a deviation control and CAPA system