Dr. Thorsten Hövel

Matrix leader in cross functional meetings to define, prioritize and implement risk analysis, containment, product hold, product recalls, corrective and preventive actions (CAPAs), complaint managment, affiliate field action, custmer notification. Broad range of interaction partners in Germany, Switzerland, China and US sites. Responsible for IVDR implementation (PSUR-PMPF-BRA-PRA). Represent quality in product care quality teams (immunology, clinchem, rapid testing -e.g SARS-COV2, POC)

Responsible for the production step of QC/standardization interlinking test components for the expected customer experience. Represent legal, official, operational requirements/regulations in cross functional teams/ audits. Monitor quality control of raw materials, intermediate and finished products for the responsible product line. Process quality management event/deviation/oos, transport damage worldwide, complaints and returns. Organize and create human material panels. Organizational size: 16

Responsible for raw material production of immunologically active components for a broad variety of products in the highly regulated good manufacturing practice (GMP) environment. Adapt and establish into production context more than a hundred products according to the design control and commercialization standard guideline. Monitor and comply with production process and quality assurance measures for approval-relevant immunologically active components for IVDR class A-D products. Organizational size: 24

Responsible for raw material production of immunologically active components for a broad variety of products in the highly regulated good manufacturing practice (GMP) environment. Organizational size: 7

Cross-interface project work in laboratories for production, in-process control, research and development on the establishment of human serum products. General protein-chemical working methods as well as special chromatographic methods in human and animal serum production.

Research in molecular virology