Dr. Detlev Zwingmann

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

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

- 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

Neuro-Immunologie