Deutschland: keine Bevorzugung, auch ganz (Ost)Europa möglich
- QA of up-stream and downstream processes
- Traceability Matrix
- Qualification of infrastructure of the IT System
- Preparing of SOPs for qualification and validation in the IT area
- Preparing qualification and validation plans
- Plannning and executing of testing
- Training in CSV proceduresValidation of computerized systems and embedded systems (controlling pharma machines); P-FMEA Risk Analyses;
URS, FS etc.
Validation of computerized systems according to GAMP 5 (own developed software [using Jira] for a pharmacovigilance database; cloud computing); preparing validation plans, FMEA risk analysis, IQ, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports.
SOP preparation for the entire QM System.
Equipment, Room Qualification, Process Validation (manufacturing of Heart-Lung-Machines)
Equipment & Room Qualification, Ebola Vaccine manufacturing; Clean room qualification; Machine validation.
Glass machines, Disposable Syringes production.
ERP-System, Data Management System, Production Control Systems
Validation of computerized systems according to GAMP 5; preparing validation plans, FMEA risk analysis, IQ, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports.
SOP preparation and review.
Validation of computerized systems according to GAMP 5 within project FDA readiness; preparing validation plans, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports (validation of Minitab 18);
Validation of Trackwise (only PQ).
Validation of computerized systems according to GAMPâ 5 within project FDA readiness; writing SOPs for CSV activitities; preparing validation plans, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Report
Vorbereitung FDA und TÜV Inspektion; Dokumenten-Review
Qualifikation von Räumen; Erstellen von SOPs; Begleitung von behördlichen Inspektionen
Erstellen von Re-Qualifizierungsunterlagen, Bedienungsanleitungen, Raumqualifizierung
Review von QA Dokumenten, Qualification & Validation von Equipment und Prozessen
QA Aufgaben, Validierung von Excel-Sheets, Transportvalidierung, CSV
Batch Record Review, QC von Kalibrierungsberichten, Raw Data Verification, Deviation Management, Complaint Management, QA/QC von Validierungsberichten
Erstellen von Validierungsberichten; Unterstützung bei FDA Inspektion, Übersetzungen ins Englische, Arbeiten mit Trackwise
Erstellen der gesamten Dokumentation für das Projekt, UAT Tests
Erstellen von Validierungsplan, URS, UAT, Test Skript, Bericht
Erstellen von URS, UATs, Validierungsplan, Validierungsbericht, Testdurchführung
VMP, UATs, Testskripte, Bericht; ERP System;
Entwurf von Testsystemen, Durchführen von Tests, Validierungspläne, Testskripts, Validierungsberichte erstellen, Abschlußbericht erstellen
Erstellen von URS, Plänen, Berichten, Entwurf von UATs, Durchführung von UATs etc.
Erstellen aller Dokumente, Pläne, URS etc.
Erstellen komplette Validierungsdokumentation, Vendoraudits, Validieren von Datentransferprozessen
QA in allen Phasen des Projektes: IQ/OQ/PQ
2011-2013
Consultancy of Ribological GmbH, Mainz, Germany
QA Manager
2010-2013
Consultancy of Ganymed AG, Mainz, Germany
QA Manager
06/2008-12/2008
Manufacturer of Monoclonal Antibodies, Ganymed AG, Mainz, Germany
QA Manager
Trainings and Workshops 2000-2012, performed by myself
Profession
1993 -1993
Freelance Auditor with CRO: Medical Consulting Dr. Ursula Schlichtiger, München, Germany
1989-1992
Director F&E with Lomapharm, Rudolf Lohmann GmbH & KG, Emmerthal, Germany
1987-1989
Head of Medical Department with Rorer GmbH, Bielefeld;
1982-1987
Clinical Research Assistant (CRA) with Wyeth GmbH, Münster, Germany
1972-1981
Assistant Professor at Institute for Biochemistry
Study
1971-1972
Assistant at Institute of Biochemistry, University, Marburg
1971-1972
Thesis in Biochemistry
1963-1971
Study of Chemistry at Philipps University Marburg/Lahn
Graduation as Dipl.Chem. (Specialization in Biochemistry, minor subjects Clinical Psychology, Philosophy)
Specific postgraduate training
Biostatistics, Monitoring, Quality Management, DIN EN ISO 9000 pp., 13485, 13408, 15189, 17025, ICH-GCP, Computer System Validation, Electronic Data Capturing, Data Management; trainings for G(A)MP Validation, V-model etc., Equipment Qualification, rooms and vehicles, cleaning and transport validation, process validation
QA/QM, Qualifizierung, Validierung, CSV, Training, SOPs
Scientific papers
More than 80 papers, book contributions, incl. approx. 20 poster presentations, abstracts, > 100 lectures
various publications
Deutschland: keine Bevorzugung, auch ganz (Ost)Europa möglich
- QA of up-stream and downstream processes
- Traceability Matrix
- Qualification of infrastructure of the IT System
- Preparing of SOPs for qualification and validation in the IT area
- Preparing qualification and validation plans
- Plannning and executing of testing
- Training in CSV proceduresValidation of computerized systems and embedded systems (controlling pharma machines); P-FMEA Risk Analyses;
URS, FS etc.
Validation of computerized systems according to GAMP 5 (own developed software [using Jira] for a pharmacovigilance database; cloud computing); preparing validation plans, FMEA risk analysis, IQ, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports.
SOP preparation for the entire QM System.
Equipment, Room Qualification, Process Validation (manufacturing of Heart-Lung-Machines)
Equipment & Room Qualification, Ebola Vaccine manufacturing; Clean room qualification; Machine validation.
Glass machines, Disposable Syringes production.
ERP-System, Data Management System, Production Control Systems
Validation of computerized systems according to GAMP 5; preparing validation plans, FMEA risk analysis, IQ, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports.
SOP preparation and review.
Validation of computerized systems according to GAMP 5 within project FDA readiness; preparing validation plans, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Reports (validation of Minitab 18);
Validation of Trackwise (only PQ).
Validation of computerized systems according to GAMPâ 5 within project FDA readiness; writing SOPs for CSV activitities; preparing validation plans, OQ and PQ documents, incl. Test Protocols (Scripts); performing tests; Validation Summary Report
Vorbereitung FDA und TÜV Inspektion; Dokumenten-Review
Qualifikation von Räumen; Erstellen von SOPs; Begleitung von behördlichen Inspektionen
Erstellen von Re-Qualifizierungsunterlagen, Bedienungsanleitungen, Raumqualifizierung
Review von QA Dokumenten, Qualification & Validation von Equipment und Prozessen
QA Aufgaben, Validierung von Excel-Sheets, Transportvalidierung, CSV
Batch Record Review, QC von Kalibrierungsberichten, Raw Data Verification, Deviation Management, Complaint Management, QA/QC von Validierungsberichten
Erstellen von Validierungsberichten; Unterstützung bei FDA Inspektion, Übersetzungen ins Englische, Arbeiten mit Trackwise
Erstellen der gesamten Dokumentation für das Projekt, UAT Tests
Erstellen von Validierungsplan, URS, UAT, Test Skript, Bericht
Erstellen von URS, UATs, Validierungsplan, Validierungsbericht, Testdurchführung
VMP, UATs, Testskripte, Bericht; ERP System;
Entwurf von Testsystemen, Durchführen von Tests, Validierungspläne, Testskripts, Validierungsberichte erstellen, Abschlußbericht erstellen
Erstellen von URS, Plänen, Berichten, Entwurf von UATs, Durchführung von UATs etc.
Erstellen aller Dokumente, Pläne, URS etc.
Erstellen komplette Validierungsdokumentation, Vendoraudits, Validieren von Datentransferprozessen
QA in allen Phasen des Projektes: IQ/OQ/PQ
2011-2013
Consultancy of Ribological GmbH, Mainz, Germany
QA Manager
2010-2013
Consultancy of Ganymed AG, Mainz, Germany
QA Manager
06/2008-12/2008
Manufacturer of Monoclonal Antibodies, Ganymed AG, Mainz, Germany
QA Manager
Trainings and Workshops 2000-2012, performed by myself
Profession
1993 -1993
Freelance Auditor with CRO: Medical Consulting Dr. Ursula Schlichtiger, München, Germany
1989-1992
Director F&E with Lomapharm, Rudolf Lohmann GmbH & KG, Emmerthal, Germany
1987-1989
Head of Medical Department with Rorer GmbH, Bielefeld;
1982-1987
Clinical Research Assistant (CRA) with Wyeth GmbH, Münster, Germany
1972-1981
Assistant Professor at Institute for Biochemistry
Study
1971-1972
Assistant at Institute of Biochemistry, University, Marburg
1971-1972
Thesis in Biochemistry
1963-1971
Study of Chemistry at Philipps University Marburg/Lahn
Graduation as Dipl.Chem. (Specialization in Biochemistry, minor subjects Clinical Psychology, Philosophy)
Specific postgraduate training
Biostatistics, Monitoring, Quality Management, DIN EN ISO 9000 pp., 13485, 13408, 15189, 17025, ICH-GCP, Computer System Validation, Electronic Data Capturing, Data Management; trainings for G(A)MP Validation, V-model etc., Equipment Qualification, rooms and vehicles, cleaning and transport validation, process validation
QA/QM, Qualifizierung, Validierung, CSV, Training, SOPs
Scientific papers
More than 80 papers, book contributions, incl. approx. 20 poster presentations, abstracts, > 100 lectures
various publications
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