Qualification Specialist, Manufacturing GMP Support | Qualifizierer in der Herstellung GMP Support (m/w/d)
Office Events P & B GmbH
Job Summary
This role involves working as a Qualification Specialist within the pharmaceutical industry, focusing on ensuring devices and systems meet current Good Manufacturing Practice (GMP) requirements, particularly during laboratory and cleanroom facility modifications. Day-to-day tasks include collaborating within an interdisciplinary project team on the conversion of facilities, planning, executing, and documenting re- and change qualifications, including Computer System Validations (CSV). The ideal candidate must possess a scientific or biotechnology degree, strong technical understanding, and fundamental knowledge of GMP regulations. The position requires several years of practical experience in qualification under GMP (URS, RA, DQ) for equipment and systems, alongside strong analytical thinking and a structured, goal-oriented working style. This is a full-time, permanent position based in Idar-Oberstein, initially offered via temporary employment with an option for permanent takeover.
Required Skills
Education
Completed degree in Natural Sciences, Biotechnology, Process Engineering, or comparable qualification
Experience
- Several years of practical experience in qualification under GMP (e.g., URS, RA, DQ) for devices and systems or Computer System Validations
- Professional experience in manufacturing GMP support
Languages
Additional
- Not specified
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