Pharm@dviser

1/2020 – 3/2024

Conception, preparation and delivery of a series of international data integrity, CSV, and cloud-based CSV web-trainings and seminars.
Training language: English

Qualitätsmanagement / QS / QA (IT), Good Manufacturing Practices, Gute Laborpraxis (GLP), Bildungswesen und Training (Sonstige), Data Science, Schulung / Training (IT), Validierungsingenieur

6/2019 – 12/2019

An OTC Drug manufacturer has received an FDA Warning Letter. In response to the FDA Warning Letter and associated agreements, 21 CFR 211 gap assessments were performed for the processes change control, supplier qualification, and computerized systems validation. CAPA actions were defined. New SOPs were written in the domain of computerized systems and data integrity.
Project language: French

IT-Auditor, Prozessoptimierung, Unternehmensberater Geschäftsprozessoptimierung, Validierungsingenieur, Change Management, Change-Request-Management, Auditor, Data Science, Good Manufacturing Practices, Qualitätsmanagement / QS / QA (IT), Qualitätsmanagement (allg.), Qualitätsverfahrensanweisung, Technisches Qualitätsmanagement / QS / QA

11/2016 – 1/2017

The QMS and operational documentation of the group IT organization of a life sciences corporation was audited in terms of compliance with CSV, data integrity and general IT QM requirements. Contract giver was an affiliated company receiving services by the group IT organization. Issues were identified and recommendations for improvements were provided.
Project languages: German

Lieferantenbewertung, Lieferantenentwicklung, Lieferantenmanagement (allg.), IT-Auditor, Good Manufacturing Practices, Auditor, Qualitätsmanagement / QS / QA (IT)

7/2016 – 8/2016

The regional and local IT QMS of a manufacturing site of a global pharmaceutical corporation has been audited. Audit subjects have been CSV, data integrity and other aspects with focus on manufacturing and QC laboratories. Contract giver was the corporate internal audit departments. Issues were identified and recommendations for improvements were provided.
Project languages: English

Softwaredokumentation, IT-Auditor, Prozessoptimierung, Auditor, Data Science, Good Manufacturing Practices, Gute Laborpraxis (GLP), Qualitätsmanagement / QS / QA (IT)

4/2016 – 12/2018

The complaint management process of a globally leading medical device corporation both for disposables and for active medical device products has been re-designed across all geographies and functional silos to meet regulatory expectations on a global level and to harmonize previous local approaches that have been replaced. A new system based on TrackWise software was developed, validated and rolled out globally (big bang approach) for both product types.
Project languages: German & English

Lieferantenbewertung, Manueller Tester IT-Qualitätssicherung, Teamleiter Softwaretesting, Test Management, Softwareanforderungsanalyse, Anforderungsspezifikationen, Good Manufacturing Practices, IT-Projektleiter, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Spezialist technische Dokumentation, Validierungsingenieur

3/2016 – 4/2016

The QMS of the group IT organization of a global pharmaceutical corporation was assessed. Contract giver was the IT organization itself (independent self-audit). Issues were identified and recommendations for improvements were provided.
Project languages: German

IT-Auditor, Prozessoptimierung, Auditor, Good Manufacturing Practices, Qualitätsmanagement / QS / QA (IT)

6/2015 – 2/2016

The SAP validation strategy in a globally leading pharmaceutical / medical devices corporation has been developed and a global SAP validation master plan been written for a major SAP template program. Training of all project members in CSV and good documentation practices. Review and approval of validation documentation. General oversight on the validation stream within the SAP template program.
Project languages: German & English

Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Good Manufacturing Practices

2/2015 – 2/2016

The SOP management process of a globally leading pharmaceutical / medical devices corporation has been re-designed across all geographies and functional silos to meet regulatory expectations on a global level and to harmonize previous local approaches that have been re-placed. A new DMS system based on Documentum software was developed and validated.
Project languages: German & English

Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Application Lifecycle Management, Good Manufacturing Practices

2/2014 – 6/2016

- 12 direct full-term reports + varying number of project-related external resources
- 6+ mio. € budget & cost center responsibility
- Maintenance and improvement of the Global Quality Management System
- Management of the global matrix certification according to ISO 9001 and 14001
- Ownership of global product independent QM processes
- Monitoring trends and changes of QM regulations & QM reporting
- Ownership of global QM projects & global QM IT Systems

Auditor, Audits, DIN EN ISO 13485, DIN EN ISO 9001, ISO 14001 (Umweltmanagement), Leiter Qualitätsmanagement, Qualitätsdokumentation, Qualitätshandbuch, Qualitätslenkung, Qualitätsverfahrensanweisung, Vizepräsident Qualitätsmanagement

2/2014 – 2/2016

A global LIMS was conceptualized, developed, validated, and rolled-out according to a module and country based roll-out plan.
Project languages: English

Qualitätsmanagement / QS / QA (IT), Application lifecycle management (ALM), Good Manufacturing Practices, Vizepräsident Qualitätsmanagement, Projektleitung / Teamleitung

2/2014 – 7/2015

The CAPA, deviation management, non-conformity management, and change management processes of a globally leading pharmaceutical / medical devices corporation have been re-designed across all geographies and functional silos to meet regulatory expectations on a global level and to harmonize previous local approaches that have been replaced. A new system based on TrackWise software was developed, validated and rolled out globally (100+ sites) for all mentioned processes.
Project languages: English

Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Application Lifecycle Management, Good Manufacturing Practices

5/2013 – 8/2013

Our customer, a leading global fine chemical corporation (incl. API production), utilizes an internal IT Service Provider for IT infrastructure and application management services. This internal IT Service Provider has been assessed in order to identify potential compliance gaps, and improvement and remediation recommendations were developed.
Project languages: German

Auditor, Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT)

5/2013 – 8/2013

The QMS of the internal IT organization of a life sciences company producing disinfectants was assessed in terms of its structure, usability, compliance overdoing or gaps. Issues were identified and recommendations for improvements were provided.
Project languages: German

Auditor, Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT)

3/2013 – 9/2013

An SAP carve-out and integration project has been accompanied from a CSV perspective within a global chemical and pharmaceutical corporation.
Project languages: German & English

Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Validierungsingenieur

11/2012 – 3/2013

CSV lead on the occasion of an ERP migration and validation project including the performance of an IT supplier audit of an IT service company responsible for the migration of all ERP data from the old ERP system into the new SAP system.

Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Validierungsingenieur, Good Manufacturing Practices, Auditor

8/2012 – 3/2013

A global TOP10 healthcare company hired us to audit a major global software and IT services provider regarding his compliance with IT regulations in the life sciences industries. The aim of this project was to qualify the software provider for use in the GxP regulated world.
Project languages: English

Auditor, Good Manufacturing Practices, Qualitätsmanagement / QS / QA (IT)

10/2011 – 5/2012

Our customer, a leading global IT Consulting firm, offers SAP application support services for some of its life sciences industry customers. These services have been assessed and a quality management manual been improved in order to meet regulatory requirements of the consuming life sciences customers.
Project languages: English

Application Lifecycle Management, Good Manufacturing Practices, IT-Auditor, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT)

8/2011 – 10/2011

A leading global cloud services provider hired us to assess the compliance of cloud infrastructure processes and services with IT regulations in the life sciences industries. The aim of this project was to analyze establish controls, identify potential gaps and write a compliance assessment re-port which can be used by the cloud services provider to fix any found issues as well as to demonstrate his compliance status to GxP regulated customers.
Project languages: English

Application Lifecycle Management, Good Manufacturing Practices, IT-Auditor, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT)

6/2010 – 10/2011

An IT QMS has been developed from scratch and been implemented within an internal IT Service Provider organization of an international chemical and pharmaceutical corporation. An SAP carve-out project has been accompanied in parallel from a CSV perspective.
Project languages: German & English

Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Qualitätsverfahrensanweisung

8/2009 – 3/2010

Corporate IT provides IT systems and services for the healthcare unit, a global Top10 healthcare corporation. Within the existing IT QMS compliance gaps were identified and re-mediated.
Project languages: German & English

Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Qualitätsverfahrensanweisung

7/2009 – 12/2009

Support of a medium-sized software vendor in creating a Management system compliant with DIN EN ISO 9000 including a structured organizational and process-oriented organization.
Project languages: German

Application Lifecycle Management, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Qualitätsverfahrensanweisung

5/2009 – 11/2009

A global Top10 Healthcare corporation is implementing a new global vendor management system for several thousands of users.
The system is GMP relevant and that is why a complete validation is necessary. Furthermore an audit of three IT vendors has been per-formed.
Project languages: German & English

Auditor, Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT)

3/2009 – 6/2009

The IT QMS and global SAP Template of a leading global medical device manufacturing corporation was analyzed for right-sizing potentials based on risk. After the identification of further risk-based right-sizing potentials, the Top10 improvement ideas were elaborated and implemented through according sub-projects.
Project languages: German

Good Manufacturing Practices, Projektleitung / Teamleitung (IT), Qualitätsmanagement / QS / QA (IT), Validierungsingenieur

2/2009 – 1/2014

- 6 direct + 5 functional + various project reports
- Several dozens of projects in Belgium, Germany, Ireland, Italy, Liechtenstein, Switzerland (project leader on all projects + Principal Consultant) such as:
- Conception and development of processes and tools in the global information risk, compliance, and audit management area of a global Top 10 pharma corporation
- Implementation of a holistic process-oriented QMS for a leading medical devices manufacturer based on a BPM platform
- Evaluation&remediation of the IT QMS for a global Top 10 healthcare corporation
- Evaluation of compliance-cost-saving potentials in the SAP area of a global Top 10 healthcare corporation
- Auditor and subsequently coach and advisor to the CEO of an IT supplier of FDA regulated companies; Set-up of a new QMS according to ISO 9000 standards
- Compliance evaluation of >100 IT systems (major remediation initiative) after a global top10 healthcare corporation received several FDA warning letters
- Evaluation reports about the compliance with 21CFR11 and German regulations of electronic signatures in the SAP system of a major generic drug manufacturer
- Supplier audits for various customers within the life sciences industries

Akquise / Kontakt, Compliance management, Management (allg.), Projektleiter im Bereich Information, Projektleitung / Teamleitung, Projektleitung / Teamleitung (IT), Projektmanagement (IT), Qualitätsmanagement / QS / QA (IT), Risikomanagement, Teamleiter, Validierungsingenieur

8/2008 – 1/2009

The existing regional QMS was analyzed for further right-sizing potentials based on risk. After the identification of further risk-based right-sizing potentials, the Top10 improvement ideas were elaborated and implemented through according sub-projects.
Project languages: English

Prozessoptimierung, Lean Prozesse, Six sigma, Good Manufacturing Practices, Qualitätsmanagement / QS / QA (IT), Qualitätsverfahrensanweisung

10/2006 – 6/2007

Existing QMS and computer system delivery processes were analyzed using the LeanSixSigma methodology with the aim of reducing overall effort and increasing employee satisfaction. Focus of improvements laid on streamlining of documentation, on testing and on the application of risk management principles.
Project languages: English

Qualitätsmanagement / QS / QA (IT), Application Lifecycle Management, Prozessoptimierung, Validierungsingenieur, Lean Prozesse, Qualitätsverfahrensanweisung, Six sigma

2/2005 – 12/2005

A QMS was developed from scratch for a newly created regional IT organization. The QMS had to take into consideration the broad variety of applying regulations (Data Privacy, Sales and Marketing Practices, GMP, SOx, etc.). Another challenge lay in the fact this organization had not been exposed to rigorous CSV, change control, periodic reviews, and other IT quality related controls in the past. Therefore a quality culture and an awareness of the risks needed to be built in parallel.
Project languages: English

Application Lifecycle Management, Good Manufacturing Practices, Qualitätshandbuch, Qualitätsmanagement / QS / QA (IT), Qualitätsverfahrensanweisung, Risikomanagement, Schulung / Training (IT), Validierungsingenieur

3/2004 – 1/2009

- 10 direct reports (mostly CSV analysts) across the EMEA region (multi-cultural, virtual team)
- Global Risk Management Task Force
- EMEA IT Quality Lead Team
- German IT Lead Team
- EMEA Sarbanes-Oxley Coordinator IT

Projektmanagement (IT), Management (allg.), Teamleiter, Projektleitung / Teamleitung, Dokumentenmanagement, Fehlermöglichkeits- und -einflussanalyse (FMEA), Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), FMEA (Failure Mode and Effects Analysis), Good Manufacturing Practices, Lieferantenbewertung, Lieferantenmanagement (allg.), Projekt-Qualitätssicherung, Prozessoptimierung, Qualitätsdokumentation, Qualitätshandbuch, Qualitätsmanagement / QS / QA (IT), Qualitätssicherungssysteme, Qualitätsverfahrensanweisung, Softwaredokumentation, Validierungsingenieur

1/2003 – 6/2003

A global SAP R/3 template was built for all global non-manufacturing affiliates of a major global pharmaceutical corporation. Tasks were the implementation of the SAP Audit Trail functionality, various CSV tasks and other SAP-related tasks.

SAP R/3, SAP PP-PI, Validierungsingenieur, Technische Dokumentation

5/2001 – 6/2003

Co-developer of the preconfigured "mySAP All-in-One Pharmaceuticals" solution

SAP BC-CUS (Customizing), SAP PP-PI, Technische Dokumentation

10/1999 – 8/2002

- Prozessteamleiter Manufacturing Execution
- Prozessteamleiter Audit Trail
- Einführung SAP PP-PI
- Einführung SAP Audit Trail

Compliance management, Fehlermöglichkeits- und Einfluss-Analyse (FMEA / FMECA), FMEA (Failure Mode and Effects Analysis), FMECA (Failure Mode and Effects and Criticality Analysis), Good Manufacturing Practices, Informationssicherheit, IT Sicherheit (allg.), Microsoft Excel, Microsoft Powerpoint, MS Office (Anwenderkenntnisse), Projektleitung / Teamleitung, Projektleitung / Teamleitung (IT), Prototyping, Qualitätsmanagement / QS / QA (IT), SAP Beratung (allg.), SAP IS-Pharma, SAP LO-BM, SAP LO-ECH, SAP MES, SAP PP-PI, SAP R/3, SAP Sicherheit (allg.), Schreiben von Dokumentation, Schulung / Training (IT), Test Management, Testen

4/1999 – 10/1999

Einführung SAP R/3 PP-PI inkl. elektronische Herstellanweisung

Prototyping, SAP-Berater, SAP PP-PI, SAP R/3

1/1999 – 12/2003

Testen und Abnahme von neu-entwickelter SAP-Funktionalität aus Sicht der Kunden in den Prozess- und LifeSciences-Industrien für die Releases 4.0B - 4.7.

Schwerpunkte: PP-PI, LO-ECH, LO-BM, Digitale Signatur (LO-DSG), Elektronische Herstellanweisung (PP-PI-PMA) und SAP Audit Trail

Digitalisierung, SAP-Berater, SAP LO-BM, SAP LO-ECH, SAP MDM, SAP PP-PI, Sap Solution Manager, Software Design, Softwareanforderungsanalyse, Softwaredokumentation, Softwaretester, System Design

11/1998 – 4/1999

Einführung SAP R/3 PP-PI und LO-ECH

SAP-Berater, SAP LO-ECH, SAP PP-PI