„Your solution partner with special know-how and wide knowledge“
Profile
- Successful as Project Manager, Validation Manager, Test Manager
- Active in the field of medical technology and pharmaceuticals with laboratory systems, insulin pumps and blood glucose meters.
- Project duration from 1 month to 3 years
- From solo project to management of project teams with up to 25 employees
- Verification and Validation
- From small devices and test stations to laboratory systems MES / LIMS
- Embedded Computing and High-level Language
- Mobile Computing and Client-Server
Education:
Computer Science at the University of Oldenburg
Expertise
- Test management
- Project management
- Verification (FDA)
- Validation of computerized systems CSV (GAMP 5)
- Manual and automatic testing of software
- Requirements engineering
Database
- SQL
- IRD DB sds
- dBase
Programming Languages
- C, C++, C#
- Microsoft Visual Basic and VBA
- Python
- Java
- Pascal, MODULA 2, Cobol
- Assembler
Standards/guidelines
- FDA 21 CFR Part 11, 820, 510k
- ISO 13485
- Eudralex Annex 11, 15
- GAMP 5
- V-Modell
Operating Systems
- MS Windows
- Sun Solaris
- Unix
- BS2000
Tools
- KNEAT paperless GxP-Validation Software
- MF ALM
- Veeva QualityDocs & DMS
- Jira
- HP QC (Mercury)
- Windream
- X-Windows (Unix)
- MES
- LIMS
Certificates
Further education
- ISTQB Certified Testmanager
- Certified Projectmanager (IHK)
- Certified Professional for Requirements Engineering Foundation Level CPRE / IREB®
- Certified Professional for Medical Software
- SAQ ISTQB Certified Tester
- Validation of Computerized Systems CSV (Computer Software Validation)
- Business Continuity Management (BCM, TÜV Rheinland Akademie, 04.2021)
- Process Validation, Risk analysis
- Qualification of equipment
- KNEAT User, Reviewer and Approver
- Veeva QualityDocs document owner
- CAPA / Deviation management
- Guidelines for the Certification of Medical Devices (Prof. Dr. Johner, Institute for IT in Health Care)
- Seminar Code Review and General Programming Guidelines
- SCRUM (agile software and product development)
- Seminar Eclipse and Java
- Seminar Software Development for the Android Operating System
- Review GMP-relevant documents
- Good documentation practice
