Qualification Specialist, Manufacturing GMP Support | Qualifizierer in der Herstellung GMP Support (m/w/d)
Office Events P & B GmbH
Job Summary
This role involves acting as a Qualification Specialist within manufacturing, focusing heavily on GMP (Good Manufacturing Practice) compliance in the pharmaceutical industry. The successful candidate will collaborate within interdisciplinary project teams, specifically assisting with the conversion and reconstruction of laboratory and cleanroom facilities. Key responsibilities include the planning, execution, and comprehensive documentation of re- and change qualifications, including crucial computer system validations. A core function of the role is ensuring that all equipment and systems, such as compressed air and CO2 supply, meet current GMP requirements following relocation or modification. Candidates must possess a scientific or engineering degree, strong technical understanding, and multi-year practical experience in GMP qualification activities (URS, RA, DQ, etc.). This position requires a structured, target-oriented approach, strong analytical skills, and the ability to work independently.
Required Skills
Education
Completed natural science degree, or a degree in Biotechnology or Process Engineering, or comparable qualification
Experience
- Multi-year practical experience as a Qualification Specialist in manufacturing GMP Support
- Experience in qualification under GMP (URS, RA, DQ, etc.) of equipment, facilities, or computer systems
- Professional experience in the pharmaceutical industry (implied by context)
Languages
Additional
- Not specified
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