Biologist | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This role focuses on ensuring regulatory compliance and operational integrity within the pharmaceutical manufacturing environment. The Biologist will be responsible for the Quality Assurance (QA) oversight of Operational Technology (OT) infrastructure and software, including validation activities for computer-based systems. Key duties involve reviewing and approving validation documents, evaluating change requests and deviations, and supporting regulatory inspections. The position requires a strong understanding of GMP guidelines, GAMP5, and relevant national/international regulations. This is an excellent opportunity for a meticulous biologist with practical OT experience in a GMP setting to contribute to a leading global healthcare company dedicated to improving lives through innovative medicines.
Required Skills
Education
Completed degree in natural sciences or comparable education
Experience
- Several years of practical OT experience in a GMP-regulated environment within QA
- Professional experience in quality assurance operations
- Experience with validation and qualification of systems
- Experience in evaluating change requests and deviations
- Experience supporting regulatory inspections
Languages
Additional
- Not specified
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