Dr. Detlev Zwingmann
Angestellt, Lead Quality Assurance Engineer Combination Products/Medical Device, CSL Behring
Marburg, Deutschland
Werdegang
Berufserfahrung von Detlev Zwingmann
Bis heute 2 Jahre und 8 Monate, seit Nov. 2021
Lead Quality Assurance Engineer Combination Products/Medical Device
CSL Behring4 Jahre, Juli 2017 - Juni 2021
Head of Quality Assurance
Beckman Coulter
Sr. Manager Quality Assurance and Quality Representative - Responsible for the Quality Assurance department at two manufacturing sites for Urinalysis and Hematology with responsibility for 21 employees with 4 hierarchy levels - Responsible for Quality Control, CAPA, Non-Conformance Process, Supplier Quality, Process Validation, Design Transfer, Change Control, DHR, Risk Management and Training - Responsible for the QMS compliance to MDSAP, ISO 13485-2016, FDA CFR 21, IVDR and M-R
3 Jahre und 8 Monate, Nov. 2013 - Juni 2017
Production Manager
DiaSorin
Production of In-vitro-diagnostic - Responsible for the production of Chemiluminescence Immunoassay (CLIA) according GMP class A; personal responsibility for 24 employees - Technologies used are FPLC and HPLC for protein and conjugate purification, main production processes are conjugation, labeling, coating, bulk preparation, filtration and filling, freeze drying and final packaging - FDA 21 CFR Part 820 and GMP, ISO 13485 and IVDR / MDR - Process Validation (IQ, OQ, PQ) and Qualification
11 Jahre und 1 Monat, Nov. 2002 - Nov. 2013
Director Production
Analyticon Biotechnologies AG
- Responsible for the production and distribution of Clinical Chemistry reagents and Urine Test Strips with complete supply chain responsibility - Budget responsibility, and personal responsibility for 27 employees - Representing production department in FDA inspection, ISO 9001 and ISO 13485 audit - Core technologies are bulk formulation, filling, analyte paper impregnation, freeze drying, cutting and bottling technology and final packaging - Safety representative according §30 MPG
Ausbildung von Detlev Zwingmann
10 Jahre und 2 Monate, Apr. 1991 - Mai 2001
Physiologie
Philipps-Universität Marburg
Neuro-Immunologie
Sprachen
Englisch
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Italienisch
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