QUALITY & COMPLIANCE MANAGER/ DIPLOM CHEMIKER/ INGENIEUR/ GMP QUALITÄTSBEAUFTRAGTER/ Auditor/CSV

6/2019 – offen

- Validation and qualification of equipment/ laboratory equipment
(construction and relocation of GMP regulated laboratories)
- Development of validation and qualification strategies
- Creation of test scripts for OQ and PQ
- Planning and implementation of all computer-aided system
activities including documentation according to the business and regulatory requirements (incl. GAMP5)

Good documentation practice (GDP, GDocP), GxP, MS Office (Anwenderkenntnisse), DIN EN ISO (allg.), Dokumentenmanagement, Gute Herstellungspraxis (GMP)

7/2018 – 12/2018

-Qualification and Validation of Hazard assessments of hydrogen-powered pilot plants (ISO 12001) and Chemicals
- Implementation and Organization of safety-relevant reconstruction measures (ISO 14001, 45001)
- Development of SOP‘s for individual work areas (high-pressure autoclave, calcination furnace)
- Supervision of master students in plant construction and other chemical issues
- Lab Safety Manager
- Documentation and execution of further research tasks

MS Office (Anwenderkenntnisse), Projekt-Qualitätssicherung, DIN EN ISO (allg.), DIN EN ISO 14001, Qualitätsdokumentation

10/2016 – 9/2018

Managing Quality Control of Asian patents and paper - Quality assurance of the database REAXYS®
- Manage the administrative process of quality reports
- Coordination of external service providers
- Establishment of a table for the verification of word-
detection methods
- Control of links to internal databases - Correction of incorrect associations
- Correction of database entries

MS Office (Anwenderkenntnisse), DIN EN ISO (allg.), Qualitätsdokumentation, Dokumentenmanagement