Experts

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Background: Certified GMP expert & internal auditor, certified validation expert in the pharmaceutical industry
Master of Arts (M.A.) Ruprecht Karls University of Heidelberg

Career milestones:

Since January 2024 Managing Director at Thomas Schmidt Consultants GmbH

2024 – 2025 Kinetics Germany GmbH
Management of the on-site documentation department, conversion/expansion
of a pharmaceutical production plant, ensuring
compliance with delivery deadlines, process and
system optimization
2021 – 2025 Boehringer Ingelheim RCV (Vienna)
Planning and execution of container inspections
and attachments, including accompanying production control at
various manufacturers, surface roughness and
ferrite content measurement, riboflavin tests, documentation

2021 – 2023 Sanofi Frankfurt
Reviewing documents for GMP compliance and investigating any deviations, operational review of batch records and cleaning validation documents, creating validation documents and plans, leading relevant training sessions, and creating training materials

Since June 2021 at Thomas Schmidt Consultants as an expert for GMP project documentation, qualification, and validation

From 2008 to 2020 Project Manager Archaeology
Excavations, scientific investigations, documentation

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Retired since December 2024

Background: Technical training at Siemens

Career milestones: Heinrich Hertz Institute (Fraunhofer Institute for New Technologies), Berlin; from 1985, Technical Director at Ultra Tube GmbH in Berlin; 1996, Sales and Marketing Director at Dräger Tescom GmbH in Lübeck; 2001 General Manager at the German subsidiary of the US company Kinetics; 2003 Q-Cells AG in Thalheim; April 2004 Joined the Executive Board of Q-Cells AG (responsible for production, QM, safety, and technical service); under his leadership, Q-Cells built up a capacity of over 600 MWp; 2007 to 2008: operational organization for CSG AG (a former thin-film technology subsidiary of Q-Cells SE)

Since May 2008: independent consultant and project manager; December 2008: founded the consulting firm TST-C (main clients: cell production companies); Founder, managing director, and shareholder of TST-C; June 2013: Re-Founding as Thomas Schmidt Consultants GmbH

Additional qualifications in biopharmaceuticals:
Modern filling practical course at Bausch + Ströbel, October 2014
Training course and qualification as QS/GMP representative, Block I, May 2014, Block II, June 2014
GMP in High Purity Piping Installations Training, July 2013
FDA-compliant Engineering Seminar, February 2002
Cost-optimized Pharmaceutical Factories Seminar, January 2001

Additional qualifications Management & Projects:
Lean Construction Training and Workshop, 2019
Maintenance Success Control Course, March 2007
Legal Pitfalls for Technical Management Seminar, January 2007
5 Modules Business Coaching, 2006 to 2007
Project Contracts Course, September 2002
Training as an expert in pressure vessel regulations, 2004 & 1992

Co-author for the media supply systems section of the LCS compendium “Planning, Setting Up, and Equipping Laboratories”