09/2023-01/2025

Validation Manager

Industry: Pharmaceutical
Company: Takeda Manufacturing Austria AG
Tasks: Validation, qualification, change and audit consultant
Systems: Off-the-shelf systems and in-house software
Methods: GAMP 5, EudraLex - Vol. 4 Annex 11 und 15

• Quality management of software and IT infrastructure
• End-to-end validation management and infrastructure qualifications
• Managing the documentation life cycle
• Planning, documentation and execution of validations and software testing
• Planning and conducting change assessments and reviews
• Training employees

01/2024-12/2024

Test Management

Industry: Pharmaceutical
Company: Roche Diagnostics GmbH
Tasks: System migration MES for several manufacturing plants
Systems: MES Rockwell PharmaSuite
Methods: CSV, GAMP 5, EudraLex - Vol. 4 Annex 11 und 15

• Test management for the system migration MES to PharmaSuite
• Creation of a robust, risk-based test concept
• Recipe and software analysis, planning and execution of recipe tests in PharmaSuite
• Documentation management of the specification and test documentation
• Creation of deviations

07/2023-12/2023

Change Management

Industry: Pharmaceutical
Company: Roche Diagnostics GmbH
Tasks: Change management, test management
Systems: Manufacturing Execution Systems Rockwell PharmaSuite
Methods: CSV, GAMP 5, EudraLex - Vol. 4 Annex 11 und 15

• Planning and documentation of software changes
• Coordination of software changes with all stakeholders
• Test preparation and execution
• Preparation of GMP quality documentation
• Tracking of isues and deviations

06/2022-06/2023

Test Management

Industry: Pharmaceuticals
Client: Roche Diagnostics GmbH
Task: Test Management MES System   
Systems: Manufacturing Execution Systems
Methods: CSV, GAMP 5, EudraLex - Vol. 4 Annex 11 und 15

• Creation of test concept for production recipes
• Test planning
• Test preparation and execution
• Creation of reports and error analysis
• Troubleshooting or mitigation

09/2020–09/2022

Consulting

Industry sector: Pharmaceuticals
Client: BioNTech SE
Task: Validation management, Requirements Management, Business Continuity Management  
Systems: Customer-developed software and database systems
Methods: CSV, GAMP 5, EudraLex Vol.4 Annex 11 und 15

• Selection and implementation planning of an application life cycle management system (ALM)
• Validation management, planning, controlling and coordination of validation activities
• Preparation of validation plans, risk analyses (FMEAs), qualification protocols (IQ, OQ, PQ), validation reports
• Business Continuity Management and Disaster Recovery Planning

01/2020–12/2021

Data integrity management

Industry: Pharmaceuticals
Client: Sanofi-Aventis Frankfurt, (via EPM)

Task: Ensure data integrity for the manufacturing processes. Creating process flow and data analysis, identification of gaps to FDA and GxP compliance, implementation of measures to achieve compliance such as validation, SOP updates, training
Systems: Laboratory and production systems
Methods: CSV, GCP, GLP, EudraLex Vol.4 Annex 11, FDA 21 CFR Part 11

• Develop an approach to capture data integrity for laboratory processes and computerized systems
• Create data integrity questionnaires for computerized systems and Excel spreadsheets
• Create and review work instruction documents (SOPs)
• Create and visualize process flow and data flow analyses
• Capture and assess data integrity for computerized systems, manufacturing processes, and laboratories
• Identify gaps to FDA and GxP compliance and propose and implement risk-based actions to establish compliance
• Train team members

Target achieved: Data Integrity increased from Maturity Level 0 to DIMM Level 1 (end of 2019) and DIMM Level 2 (end of 2020).

06/2018-12/2019

Executive board of pw aktiengesellschaft, 85609 Aschheim near Munich

Services provided by PW AG

• IT Service
• Quality Management
• Change Management
• Training

08/2017–12/2019

Project management and validation management

Industry sector: Pharmaceuticals
Client: BioNTech SE, (via HGP, NNIT)
Task: Project Management, Consultant QA, Validation management of automated laboratory and manufacturing systems
Systems: MES (Siemens), LIMS (LabWare), Preactor (Siemens), customer-owned software and database systems
Methods: CSV, GAMP 5

• Multi-project management at the department Validation of Digital Systems (12 team member)
• Collaboration on new CSV SOP framework compliant with EudraLex and FDA requirements
• Consultant Quality Assurance (QA), Review and appoval of CSV Documents
• Validation management, planning, controlling and coordination of validation activities
• Preparation of validation plans, risk analyses (FMEAs), qualification protocols (IQ, OQ, PQ), validation reports

05/2017–07/2017

Expansion of business areas

• Expansion of industries from medical technology to pharmaceuticals with methods GAMP 5 and CSV
• Preparation for Board membership PW AG

10/2016–04/2017

Consulting and Co-Project Management Offshore Project

Quality assurance of an offshore software development and verification project
Subject: Combination continuous blood glucose monitoring, insulin pump, Smartphone (Android)

Project coordination

• Monitoring of costs, deadlines and specifications
• Coordination of the verification team on site
• Preparation of project-specific documentation
• Review of documents

Quality assurance

• Monitoring the quality of verification documents
• Monitoring and execution of offshore ad-hoc tests
• Creation of test specifications for system tests
• Creation of test scripts for the automation of software system tests

05/2015–09/2016

Project Management Software Verification

Test item: Combination blood glucose meter and insulin management software

• Project, budget and time planning
• Leadership of the project team (25 team member)
• Monitoring and control of project progress
• Coordination, organisation and motivation of project staff from different companies and disciplines to form high-performance, goal-oriented project teams. Qualifications: Engineers, physicists, mathematicians, computer scientists
• Cooperation with different technical departments of the customer
• Communication of progress to the customer
• Presentation of the project success to the customer