Qualification Specialist in 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 a pharmaceutical manufacturing environment, focusing on ensuring compliance with Good Manufacturing Practice (GMP) regulations. The successful candidate will collaborate within an interdisciplinary project team, specifically supporting the conversion and modification of laboratory and cleanroom facilities. Key responsibilities include the planning, execution, and documentation of re- and change qualifications, including Computer System Validations. A critical part of the job is ensuring that all equipment and systems, such as compressed air and CO2 supply, meet current GMP requirements following relocation or modification. This position requires a scientific background, strong technical understanding, and multi-year practical experience in qualification under GMP guidelines (URS, RA, DQ, etc.). The role demands independent, structured, and goal-oriented work, coupled with excellent analytical and problem-solving skills.
Required Skills
Education
Completed university degree in Natural Sciences, Biotechnology, 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 and systems
- Experience with Computer System Validations
Languages
Additional
- Not specified
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