Ingelheim am Rhein, Rhineland-Palatinate, Germany
Knowledge creates ways: To look at tasks holistically is his trademark. Peter Riechel uses his more than 20 years of experience in the field of life sciences in all areas and in all forms of industry. At Leibniz University Hannover he did his doctorate in the field of analytical method development for biomolecules - afterwards he took on leadership positions in the pharmaceutical industry and the independent management of projects in the pharmaceutical and medical device industry. In addition, Peter Riechel is a certified lead auditor for medical devices in accordance with ISO 13485 and ISO 9001. As you can see, you can be a generalist and a specialist at the same time. And that is how his work for Clear Cube is described in an accurate manner.
T3GxPedia Consulting – GxP & Quality Excellence for Pharma and Medical Devices Consulting, interim management and training along the entire product life cycle. www.t3gxpedia.com
Project history: - BAG Health Care, Germany: interim Head of QA - sterile manufacturing - Aicuris, Germany: CMC development - MiP Pharma, Germany: interim Head of QA - Speransa Therapeutics, Germany: interim Head of Quality - Boehringer Ingelheim, Germany: cGMP consultant for QA/QM topics for Drug Device Combination Products - Fresenius Kabi, Norway: cGMP consultant - implementation assessments of global QA SOPs - Austar Group, China: conception and execution of remote training sessions, e.g. EU GMP Annex 16; MAH concept, Third Party Management - BioNTech, Germany: cGMP consultant for Quality Agreements - ISO 9001 for lawyers. (Streitbörger, Germany) - Coin Industry, QM and Management consultant (Münz-Prägstatt München) Dr Müller, Switzerland: cGMP consultant: gap assessment / risk analysis of production process & QMS for single-use filtration units DePuy Synthes, Switzerland: QM consultant for CAPA, investigation / inspection readiness/ risk management / management review - consultant for medical device development (Hauni Vaping Technologies GmbH, Germany) Medac Germany: Interim Manager and consultant for MDR implementation, combination products - cGMP consultant: gap assessment / risk analysis of production process (Kuraray Europe GmbH, Germany) - Merck Germany: regulatory CMC compliance, module 3 CTD, in-licensing of generics. - Fresenius Medical Care, Germany: FDA readiness. Remediation. CAPA and Deviation Management. - QM consultant (Siegrist AG, Switzerland), preparation / accompanying initial ISO 13485:2016 certification. QMS Gap assessment, Risk management (ISO 14971) - cGMP consultant (Merck Germany), FDA readiness project, gap assessment and risk analysis (ICH Q9) of batch record review and QP batch certification process, transformation project. Project Management, Deviation Management, Change Control. - Medical Device Industry: Interim-Manager, Head of Quality, (DePuy Synthes, Switzerland) 9 direct reports, 60 persons within Quality Organization:
Responsible Team Member in Complaint Cycle Time Improvement Project Lean Process Mapping and Analysis Develop decision tree driven investigations Re-design of the new PTC process Responsible for the PTC process at Site Frankfurt Insulin