Thomas (W.) H.
Sales Partner
Experience
Sales Partner
SourceWeb Group
Consulting and sales of cybersecurity
Senior CSV Consultant
Valicare GmbH
Supported various projects in software validations, QMS and ISMS audits (ISO 9001 and ISO 27001), responding to customer questionnaires and GAMP® workshops; B2B customer acquisition; developing the CSV training department.
Validation Expert & Lead Auditor
PB Swiss Tools AG
Validation expert & lead auditor for medical devices; auditing an IT infrastructure cloud service provider regarding cybersecurity ISMS (ISO 27001).
Founder
Ingenieurbüro CSV CSG Computerisierte System Validierung Consulting Services Gruppe
Lead Auditor
Qualifyze GmbH
Lead auditor for GAMP, GMP, GDP and ISMS.
Use of AI / LMs to assist in creating documents, articles, graphics, images and videos.
Online-Trainingsdienstleistung IT-Testing.de®
CSVAkademie including GAMP® in its 2nd edition.
Managing Partner
IT-Testing.ch GmbH
Business consulting for validation management, project management, quality management and test management.
Qualification Expert
PB Swiss Tools AG
Qualification expert for outsourced IT infrastructure.
IT SME (Subject Matter Expert), Validation SME, CSV SME, IT Director ad interim, Validation Manager & Test Manager
aap Implantate AG
- IT SME (Subject Matter Expert) for evaluating IT service providers.
- Validation SME for the migration of BabtecQ.
- CSV SME for the requalification of proALPHA.
- IT Director ad interim.
- Validation Manager & Test Manager.
IT Testing Expert & Test Manager
KION Group AG
Testing of functional, financial and fiscal IT systems in the operational units in China, India, Australia and Europe.
IT Testing Expert & Test Manager
KION Group AG
Testing of functional, financial and fiscal IT systems in the operational units in China, India, Australia and Europe.
CSV and Test Expert
BioNTech SE
Test manager, OQ and PQ test script author and tester for an MES including interfaces to LIMS and GUS for the production of vaccines for cancer treatment according to GAMP® 5.
Quality Assurance Manager, Author
Boehringer Ingelheim GmbH & Co. KG
- Quality Assurance Manager as Senior QA Consultant (IT CSV&C function (Computerized System Validation & Compliance) according to GAMP® 5 in Europe and worldwide).
- Validation of applications and qualification of IT infrastructures.
- Trainer worldwide for the internal validation approach (LeVA – Lean Validation Approach).
- Management and maintenance of the SAP-based IT document management system.
- Reviewing the pharma-specific and related IT-specific work instructions and work templates according to GxP requirements and compliance with 21 CFR Part 11 and Annex 11, including employee training.
- Consulting for internal customer projects and external cloud computing service providers, as well as strategic outsourcing of IT infrastructures as cloud services (SAP including HANA (IaaS), AS400 (PaaS) and monitoring (SaaS)).
- Audit lead for supplier audits.
- Author of SLC documentation (System Life Cycle) for four ERP systems based on compliance requirements (GAMP® 5, GxP).
Test Manager, Team Leader and Deputy Project Manager
Commerzbank AG
Non-functional testing of core business processes related to merging the customer data of two banks; administration of HP QualityCenter.
Test Analyst, Test Manager and Deputy Team Leader
Commerzbank AG
Development of a generic EAI for connecting corporate customer data as master data to SAP MARK and a CRM system.
Managing Partner
IT-Testing.de Beratungsgesellschaft für Projektmanagement und Qualitätssicherung mbH
Head of the "Business Consulting" division.
Head of the Requirements Management and Test Management Teams, Specialist
Fraport AG
- Head of the requirements management and test management teams for departure management and resource management, including testing, calibration and simulation based on business processes, functional and non-functional tests according to ISTQB.
- Specialist in analyzing and documenting process data flows between the systems of Fraport AG's control towers and Deutsche Flugsicherung GmbH.
Lead QA and Test Manager
Deutsche Post AG
New development and further development of the existing checkout system at the software level for the service area; team lead for QA in the backend area (6 projects).
Owner
Ingenieurbüro IT-Testing.de®
Business consulting for validation management, project management, quality management and test management.
Senior Consultant
IBM Business Consulting Services GmbH
Senior consultant and test manager, e.g. on projects at Cortal Consors in Nuremberg, for the development of an online finance portal.
Principal Consultant
PricewaterhouseCoopers Unternehmensberatung GmbH
Principal consultant, test manager and project manager on projects at Infineon (Munich), Bankgesellschaft Berlin, Vodafone (Düsseldorf) and Lufthansa AG (Frankfurt).
Task Lead and Project Manager
Fraport AG
Task lead, project manager and test manager for airside projects such as the development of the Airport Operational Database (AODB), Emergency Information Data (EID), Year 2000 problem (Y2K) and the marketing of air traffic, passenger and cargo data.
Student Assistant
Various Companies
Student assistant in plant engineering, healthcare, aviation and IT.
Languages
Education
Technical University Darmstadt
Degreed engineer · Civil Engineering · Darmstadt, Germany · Good
Rheinisch-Westfälische Hochschule
Pre-degreed engineer · Civil Engineering · Aachen, Germany
Certifications & licenses
ISTQB Test Analyst, Advanced Level
ISTQB
ISTQB Test Manager, Advanced Level
ISTQB
ISTQB Certified Tester, Foundation Level
ISTQB
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