Dr. Lutz Götze

Qualitätsmanagement, Reklamationsbearbeitung, Audits, Management Review, SWOT-Analyse, Reporting, KPI´s

Quality Assurance of GLP Biorepository, GLP inspections, client and third party audits, vendor qualification, process based and facility audits, archiving of clinical study samples, specimen, tissue and study data, QA management, change control, training and process optimization

Release of fine chemicals, biologics, biochemicals and intermediates, QC and QA, vendor qualification, audit management, communication to authorities, lab management, trainings, Gemba walks, close contact to strategic purchasing, incoming goods and part of management board, KPI trending and reporting, investigations, complaints and issue management, approval, confidential agreements, reporting of BSA, TSE and other regulatory and hazard statements, process management

Programmierung, Doku, Programmtest, Debugging, Praktikum IT-Laborsupport (GSK/ Pharmaserv GmbH), Business-IT, IT-Infrastruktur, IT-Netzwerke, Helpdesk, Incident Management, Customer Service Grundlagen Webdesign, Datenbanken und Programmierung HTML; CSS, PHP, SQL, C, Java, BWL, Marketing, Recht

Qualitätskontrolle von Dentalmaterialien und medizinitechnischem Zubehör, Prozessoptimierung, Gerätequalifizierung, werkstoffwissenschaftliche Tests, Rheologie, Reklamationsbearbeitung, kontinuierliche Verbesserungsprozesse, SOP´s, Changes, Änderung von Herstellvorschriften, Personalschulungen, Review von Prüfmittelüberprüfungen, Rohstoffe, Endprodukte, Verpackungen, Zubehör

Prozessoptimierung Produktion MDR, GMP, IVD

Strukturaufklärung, LC-MS-Kopplung hochauflösende Massenspektrometrie (TOF, TRAP) Biotechnologie, qualititative und quantitative instrumentelle Analytik, Toxine, Peptidantibiotika, rekombinante Proteine, Biomarker