Beschreibung
GMP Validation Engineer
Assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data.
Responsibilities:
- Development of validation documents (i.a. IQOQ, FAT, SAT, Design Specifications)
- Execution and documentation of Acceptance Tests at Factory (FATs) and at customer site (SATs) and IQOQs at company and/or at customer site
- Cooperation with customers, project team as well as with internal software and hardware development Teams
- Monitoring all project-related activities including completeness of documentation
- Development of test protocols for internal testing and tests on customer site
Qualifications:
- University Degree/equivalent education in System Engineering, Pharmaceutical Technology, Automation, Technical Documentation
- Experience in equipment qualification and validation of computerized systems in the pharmaceutical environment
- Knowledge in pharmaceutical industry, image processing, Track & Trace and experience with coding standards (GS1, Brazil, China) is highly beneficial
- Experience in editorial systems, especially in Cosima Go disired
- Fluent in German & English; further foreign languages are beneficial
Nice to Haves:
- Experience in Track & Trace
- Experience in coding standards (GS1, Brazil, China)
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.