arete, (GR: ἀρετή ) – Excellence, of the highest quality
Consulting and interim management – quality assurance in medical devices, pharmaceuticals and biotechnology.
Hi, I am Matthias
My professional expertise has several facets, one scientific – 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 (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 – or MINT – 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’s exactly what I managed to do. I speak English and Spanish fluently and now have a basic knowledge of other languages. This makes communication in multicultural teams much easier.
Professionally, I now have the great fortune of being able to combine all my interests and passions. I like challenging scientific and technical projects in different countries in 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
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. If possible and desired, I establish new processes instead of just solving the acute problem ad hoc.
Due to my many years of experience with a wide variety of projects, I quickly learn the ropes and am your proactive collaborator from the very beginning. I take stock, go into planning and am not afraid to ask questions of any kind. Knowing the stumbling blocks and challenges, I work goal-oriented and efficiently to deliver a reliable result on time. I am also happy to take on project management and team leadership tasks.
Services
Qualification / Validation, especially CSV, incl. DQ, IQ, OQ, PQ.
Team leadership, project management
GxP, GAMP5
Audit trail, data integrity, 21CFR pt 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
Since 09/2023
Remediation Project Data Integrity Audit Trail
QA Audit Trail Expert, Alvotech, Reykjavik, ISL
Update of audit trail review process.
Training and guidance of the QA AT team.
Support 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 Operational Technology, AmpTec (Merck KGaA), Hamburg, DE
Design, ordering, installation, operation and maintenance of equipment at two production sites.
Establishment, implementation and maintenance of qualification and validation processes for GMP-compliant system operation
Support in case of deviations, change control, CAPA
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
Project work Evaluation of data integrity of packaging plants (solid dosage forms) and derivation of recommendations for action
Contact
If you are looking for a reliable QA Manager to support you in difficult project phases with expertise and efficiency, please feel free to contact us via email: mbr@arete-consult.eu