Representative QA Operations Qualification | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This role involves contributing to the qualification of facilities, equipment, and utility systems, as well as analytical devices and computer-aided laboratory systems, in a GMP-regulated environment. The successful candidate will participate in the validation of software and computer-aided systems according to current guidelines, working across all phases of qualification and validation projects (DQ, IQ, OQ, PQ). Key responsibilities include creating and maintaining validation and qualification documents, assessing change requests for GMP compliance, ensuring adherence to regulatory requirements, and preparing documentation for authority inspections. This position offers an opportunity to work within a global pharmaceutical company dedicated to improving patient lives, focusing on quality assurance in a dynamic and interdisciplinary setting.
Required Skills
Education
Completed scientific degree or comparable training
Experience
- Initial practical QA experience in a GMP-regulated environment with a focus on qualification and validation (including CSV)
- Experience in pharmaceutical sterile production is an advantage
Languages
Additional
- Not specified
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