Dr. Aubeck is responsible for the US GMP compliance business, supporting many international pharmaceutical and biotech companies to successfully pass FDA inspections. He graduated with a PhD degree in Chemistry in 1991. Dr. Aubeck has over 30-year experience in biopharmaceutical and cGMP consulting. He is also the member of the German Chemists Association (GdCh) and alumni of the European Academy of Management and Technology (EMST).

Before joining gempex Germany, Dr. Aubeck has worked in Bristol-Myers Squibb Swords, the Quality Operations Biologics Director in EU and ASIA. He also worked as a registered quality auditor in Pfizer, Sanofi-Aventis, with other experience on quality management and compliance management in global pharmaceutical companies.

Dr.Martin Melzer is the EU compliance consultant. Hegraduated from the University of Freiburg & Tübingen, Germany in 1995, and received his PhD degree from the department of pharmaceutical biology. Dr.Martin Melzer has over 27 years of GMP consulting and inspection experience. And he has QP(Qualified Person) qualification. During being as a GMP inspector German Health Authority, he has managed inspections in sterile pharmaceuticals, blood and blood products, biological products, GDP, API, and other application fields in many countries.

Since serving as a consultant in 2013, Dr. Martin Melzer has managed GMP compliance and inspection projects in many countries (Germany, Switzerland, China, etc.), and inspections and audits cover pharmaceuticals (sterile/non-sterile), blood products, biotechnology, API, excipients and packaging materials, etc.

Dr. Georg Schwarz is an IT principal consultant, and member of GMP consulting in IT team.Dr. Georg Schwarz received his Natural Sciences PhD degree in Heidelberg University in 1993. He has nearly 30 years of experience in the biopharmaceutical and consulting industry, including 24 years of experience in computerized system management and validation in the pharmaceutical field.Dr. Georg Schwarz has been responsible for GMP compliance in Novartis Pharma GmbHand at AstraZeneca application manager of several GMP solutions. He is familiar with EU GMP guidelines, US FDA21 CFR Chapter 11, ISPE GAMP5, ISO20000 and other regulatory guidelines.

Dr. Georg Schwarz has a deep knowledge background in GMP validation, IT security risk management, software development, data analysis and equipment technology knowledge, and has implemented and managed more than 50 projects.

Mr.Raimund Brett is gempex principal consultant, and he mainly focuses on pharma and biotechnology. He received a professional bachelor’s degree in pharmacy from the chamber of commerce and industry in Germany and is a member of the German Association for Quality Management, the Pharmaceutical Association for Injectable Medicines, and the Association for Life Sciences. He has 40 years of experience in the pharmaceutical industry for small and large molecules.

During his professional career, he has worked for well-known companies like Pfizer GmbH, Glatt GmbH and Novartis Pharma AG, Schwitzerland etc.

Mr.Raimund Brett is familiar with process plants and equipment, utilities, and related technologies such as cleanroom, CIP/SIP, formulation products, etc. He has professional knowledge such as development and production of solid and liquid formulations, development, and production of biotechnology (vaccines, ATMPs) and classics quality management of drugs (small molecules) and medical products (in vitro diagnostics).

Mr. Michael Jaroschis a principal consultant at gempex with a chemistry background. He has over 30 years of experience with GMP compliance. Mr. Michael Jarosch has served as Head of Quality Assurance for several pharmaceutical companies. He worked at Dr. Franz Köhler Chemie GmbH for 17 years, where he was responsible for subsequent approval as well as development and validation of analytical methods, GMP compliance and coordination of qualification and validation projects. Furthermore, he worked at Dr. Reckeweg & Co. GmbHas a Head of Quality Assurance.

Mr. Michael Jarosch is familiar with US FDA/EU/ICH regulatory compliance and has rich experience in laboratory, qualification and validation, audit and inspection, quality systems etc.

Mr.Tim Ohlrich is gempex principal consultant, and he is a team leader of GMP consulting in biotechnology. He has nearly 20 years of experience in GMP compliance. He received his master’s degree in biotechnology engineering.

Mr.Tim Ohlrich is familiar with various equipment and technologies, especially in the field of biotechnology. Besides international GMP expertise, he has a deep accumulation of knowledge in storage, logistics, quality management of transportation, warehouse design and validation, and transportation validation.

Mr.Tim Ohlrich has participated in typical projects including project management of several new factories in Europe, vaccine projects of global pharmaceutical companies, technology transfer, qualification and validation, protein and antibody reconstruction production line projects of large antibody companies, and GDP guideline implementation consulting services, quality management System consultation, gap analysis, etc.

Mr. Eric Zhong is the international compliance manager with the Pharmacy background and licensed pharmacist. More than 10 years of pharmaceutical and GMP consulting experience, he was responsible for the quality management system and inspection of the quality laboratory in a biopharmaceutical company, and for the estabalishment of the quality system of medical devices.

Mr. Eric has rich professional knowledge of GMP quality management, and is good at audit, quality system and MAH activities. He has been involved in and managed a large number of projects and compliance services covering a wide range of products, such as biotechnology, pharmaceutical preparations, sterile products, cell therapies and ADCs, and is familiar with the key factors affecting product quality and international compliance requirements. 

Currently Mr. Eric responsibles for gempex MAH compliance projects and international audit projects, serving customers and markets covering China, Europe, the United States, Japan, South Korea, etc.

Mr. Thomas He is GMP manager to for compliance GMP projects with the pharmaceutical engineering background and licensed pharmacist . He has over ten years of practical experience in famous pharmaceutical companies and GMP consulting industry and has rich of experience in GMP project management.

Mr. He is familiar with quality management of API, sterility and biotechnology. It has served dozens of typical international compliance requirements projects (FDA, EU and NMPA), covering new plant design review, QMS, qualification and validation, supplier audit, aseptic and biotechnology European and American compliance analysis, process validation and cleaning validation.

Mr. Peter Jin is the leader of IT validation of gempex China. He as over ten years of work experience in computerized system validation in the pharmaceutical industry and rich experience in GMP project consulting. Mr. Jin has pharmaceutical engineering background, and he has worked in famous pharmaceutical companies before joining gempex China.

Mr. Jin is familiar with international computerized system management and data integrity requirements, such as ISPE GAMP 5, FDA 21CFR Part 11, EU GMP, US cGMP, WHO and NMPA etc. related regulations and guidelines. He is good at the construction of computerized system management system in the pharmaceutical industry, CSV compliance gap analysis, CSV validation projects guidance and implementation of (such as DCS, BMS, WMS, ERP and customized 5 types of software validation, etc.), as well as data integrity analysis and CSV training. At the same time, Mr. Jin is also familiar with the upstream and downstream processes of API, preparations, biotechnology factories, as well as equipment knowledge and related technologies such as GMP public systems.