Jobbeschreibung
We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
#careerswithapurpose at Fresenius
Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
- Monitoring and securing GxP compliance according to internal policies and regulatory standards.
- Managing activities to maintain quality management system compliance, including document, change, and deviation management.
- Preparing, updating, and reviewing quality management documents such as SOPs, work instructions, guidance, and validation documents.
- Planning and conducting trainings on quality techniques and regulations (e.g. CSV, EU GMP).
- Having responsibility as Quality Manager for GxP-relevant computerized systems
- Validation of QM/RA processes in GxP-relevant computerized systems across the entire system life cycle (e.g. development of strategies, preparation of plans/reports).
- Coordinating periodic reviews of systems and processes.
- Participating as a GxP compliance expert in supplier audits and collaborating with Fresenius Kabi internal IT on GxP activities.
- Completed studies in natural science (such as biochemistry, biology, pharmacy, mathematics) or engineering (such as biotechnology, medical technology)
- Minimum of three years of experience in a GxP regulated environment, especially in quality management
- Advanced expertise in validating GxP-relevant computerized systems
- Good knowledge of GAMP 5 and relevant regulations (e.g. 21 CFR Part 11 and EU GMP Annex 11)
- Familiarity with electronic systems used in Quality Management (QM) and Regulatory Affairs (RA)
- Experience with both traditional and agile project management methodologies as well as first experiences with AI in the GxP environment
- Excellent English language skills (spoken and written), along with experience working in virtual and multicultural teams
- Team-oriented with high quality awareness, confident communication, intercultural competence, solution-oriented and structured thinking, independence, organizational strength, and advanced software skills (MS Office, Visio, SharePoint, Trackwise, Documentum)