arete, (GR: ἀρετή) – Excellence, of the highest quality
Quality assurance, delivered on time and built to last.
Consulting and interim management for quality assurance in medical devices, pharmaceuticals and biotechnology.
Get in touchIntroduction
Hi, I am Matthias
My professional expertise has several facets: one scientific and mathematical, one economic, one technical, and one multicultural. I have always been fascinated by science and mathematics, so I decided to study chemistry and subsequently obtained a university certificate in business administration.
Already during my chemistry studies I expanded my computer and IT knowledge out of personal interest. At that time the internet was just starting and access was only possible via university computers. In 1995 I had my first own computer (a Mac Performa 5200) and my monthly phone bill for the dial-up fees to the university was regularly over 100 DM 😉
Science, maths and technology would be enough for many. But since I have a talent for languages and like to travel, I voluntarily learned Spanish during my chemistry studies with the goal of spending a semester abroad in Spain — and that is exactly what I managed to do. I speak English and Spanish fluently and now have a basic knowledge of other languages, which makes communication in multicultural teams much easier.
Professionally, I now have the great fortune of being able to combine all of my interests and passions. I enjoy challenging scientific and technical projects in different countries and multicultural teams. I have a wide range of interests, think very analytically, am great at mental arithmetic, read several books a month, and regularly continue my education.
Summary
How I work
QA projects are usually urgent and often idiosyncratic. Many companies then need external resources to support their own team. I am your expert to execute your QA projects on time, efficiently and safely. My focus is on sustainability: where possible and desired, I establish new processes instead of just solving the acute problem ad hoc.
Thanks to my many years of experience across a wide variety of projects, I quickly learn the ropes and am your proactive collaborator from the very beginning. I take stock, move into planning, and am not afraid to ask questions of any kind. Knowing the stumbling blocks and challenges, I work in a goal-oriented and efficient way to deliver a reliable result on time. I am also happy to take on project management and team leadership tasks.
Services
What I deliver
- Qualification / validation, especially CSV, incl. DQ, IQ, OQ, PQ
- Team leadership and project management
- GxP, GAMP 5
- Audit trail, data integrity, 21 CFR Part 11, EU GMP Annex 11, data migration
- Documentation: writing and revision of SOPs including flow charts (MS Visio)
-
Complete life cycle of:
- Validation Plan (VP)
- System Assessment (IA)
- Supplier Assessment (SA)
- User Requirements (URS)
- Functional Requirements (FS)
- Risk Assessment (RA)
- Traceability Matrix (TM)
- Test Plan (TP)
- Test Cases (TC)
- Test Report (TR)
- Validation Report (VR)
Projects
Engagements
-
Since 07/2025
CSV / Automation, Biotechnology
Sr CSV / Automation Expert · Daiichi Sankyo, Pfaffenhofen, DE
Commissioning, qualification and validation of process control systems. Planning, monitoring and implementation of qualification and validation incl. VP, RA, URS, DQ, IQ, OQ, PQ. Coordination with stakeholders (business, IT and QA).
-
06/2025 – 09/2025
CSV of Excel for quality control
CSV Expert · Beiersdorf, Hamburg, DE
Creation of validation documents (VP, RA, URS, TP, TC, TM and VR).
-
09/2024 – 06/2025
SOP harmonisation, validation of laboratory systems
Sr CSV Expert · Merz Aesthetics, Frankfurt, DE
Creation of validation documents (VP, RA, URS, TP, TC and VR). Lead of the SOP harmonisation project: analysis of the existing SOP landscape, revision of existing SOPs, creation of new SOPs, coordination with stakeholders (business, IT and QA).
-
04/2024 – 07/2024
Validation / automation of filling lines
Validation Project Lead · Procter & Gamble, Frankfurt, DE
Creation of validation documents (VP, RA, URS, TM, DIA, VR). Development and validation of the data flow. Creation of SOPs. Training and guidance of the QA team.
-
09/2023 – 02/2024
Remediation Project — Data Integrity Audit Trail
QA Audit Trail Expert · Alvotech, Reykjavik, IS
Update of the audit trail review process. Training and guidance of the QA AT team. Support for the Win 10 / Win 11 GxP rollout.
-
06/2023
Qualification of high-purity media
Qualification Expert · Ferring GmbH, Kiel, DE
IOQ of high-purity media.
-
03/2023 – 07/2023
Team Lead — Operational Technology
Head of OT and IT · AmpTec (Merck KGaA), Hamburg, DE
Establishment, implementation and maintenance of qualification and validation processes for GMP-compliant system operation. Support with deviations and changes.
-
05/2022 – 04/2023
Qualification of production and filling lines
Qualification Expert · Vet Pharma (MSD), Friesoythe, DE
Design qualification (DQ, URS, FRS, FAT, SAT) and commissioning. Risk assessments as well as IQ, OQ and PQ. CSV in cooperation with IT and process automation.
-
03/2022 – 05/2022
Data Integrity — packaging equipment
Qualification Expert · Catalent, Schorndorf, DE
Evaluation of the data integrity of packaging plants (solid dosage forms) and derivation of recommendations for action.
-
08/2021 – 04/2022
Project Management — Equipment Qualification
Qualification Expert · GSK, Dresden, DE
Project management for the qualification of new laboratory equipment. Full CSV lifecycle considering GxP, 21 CFR 11, Annex 11.
-
01/2021 – 12/2021
Program Lead Win10 Lab
Project Manager CSV · Sanofi, Frankfurt, DE
Coordination of the Win 10 rollout to 100+ lab systems and corresponding validation activities per GAMP 5, 21 CFR 11, Annex 11, GMP. Focus on data integrity (gaps, risks, mitigation and remediation).
-
01/2021 – 09/2021
CSV Engineer
CSV Lead Expertise · Alvotech GmbH, Hannover, DE
Ensuring GMP compliance (Annex 11, GAMP 5 etc.). Implementation, maintenance, monitoring and improvement of relevant SOPs. Maintaining a validated state of computerised systems.
-
09/2020 – 10/2020
Equipment FAT
Automation Engineer · MSD Ireland, Carlow, IE
Review of test documentation created by suppliers. Execution of the equipment FAT. Review and approval of the qualification documentation.
-
06/2020 – 08/2020
CSV Team Lead (Automation)
Senior CSV Engineer · Biogen, Solothurn, CH
Oversight and execution of CSV activities. Creation / revision of test documentation. Implementation of the global CSV program.
-
11/2019 – 08/2020
CSV / Automation
CSV Lead Expertise · MSD AH Danube Biotech, Krems, AT
Review and approval of supplier-provided test documentation. Support for management of software FAT execution. Development of high-level SDLC documentation (QAPs, QASRs etc.).
-
09/2018 – 12/2019
Project Management IT / CSV
IT CSV Project Manager · Ethicon, J&J, Norderstedt, DE
Identification of IT-dependent systems and project management. Production IT systems: ERP/JDE, MES, Labeling, LIMS, interfaces. Change management: coordinating changes, defining resources.
-
08/2019 – 10/2019
CSV Project Management
CSV Expert · Mucos Pharma, Berlin, DE
Gap assessments and development of a mitigation plan. Assessment of global SOPs and transfer of applicable SOPs to the local QMS. Validation of computer systems.
-
01/2018 – 03/2019
IT System Management and Validation
Validation Specialist · Novartis, Basel, CH
Coordination of validation activities for laboratory systems. Writing SOPs, change management, qualification and migration. Performing IQ, OQ and PQ.
-
11/2017 – 12/2018
CSV database
CSV Project Manager · Octapharma, Hanover, DE
Creation of the validation plan, UFRS, RA, TRM, VR (Annex 11). Training and development of team members.
-
02/2016 – 12/2017
Computer System Validation & Equipment Qualification
Interim Manager CSV · Vet Pharma (MSD), Friesoythe, DE
Validation of laboratory equipment and the associated software. Performing data integrity assessments and supplier qualification.
-
02/2017 – 05/2017
CSV QlikView BI Dashboard
CSV Validation Officer · Boehringer, Dortmund, DE
Creation of requirement specifications and test cases. Review and revision of technical documentation (ISO 13485).
-
08/2015 – 12/2015
Technical Documentation, Quality Management
Technical Writer · DePuy Synthes, Balsthal, CH
Document change control / versioning. Creation and maintenance of Quality Progress Reports & QSM Reports.
-
04/2015 – 08/2015
Design & revision of master production records
Medical Writer · Rentschler Biotechnologie, Laupheim, DE
Creation and revision of manufacturing records. Revision of process flow charts (MS Visio).
-
03/2015 – 07/2015
Computer System Validation, SAP BW
Validation Officer · CSL Behring, Marburg, DE
Initial risk assessments and validation plan per GMP Annex 11. Revision of change and test procedures.
-
04/2014 – 12/2014
Retrospective CSV, legacy applications
Project Manager · DePuy Synthes, Hägendorf, CH
Leading a documentation team (4 staff). Retrospective validation of Access databases and Excel workbooks.
-
07/2013 – 12/2013
FDA QSR — Legacy Management Reviews
Quality Regulatory Consultant · Synthes, Mezzovico, CH
21 CFR 820: Legacy Management Reviews. Presentation of quality risks and implementation of corrective actions.
-
06/2013 – 10/2013
Computer System Validation, QlikView BI server
Technical Writer · CSL Behring, Marburg, DE
Development and execution of the validation plan per GMP Annex 11. Creation of DQ/IQ/OQ documents.
-
04/2012 – 04/2013
Business Development Manager
Project Management · Wick Hill GmbH, Hamburg, DE
Preparation of business plans, analyses and forecasts.
Contact
Let's talk
If you are looking for a reliable QA manager to support you through difficult project phases with expertise and efficiency, feel free to get in touch by email.
mbr arete-consult eu