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 heavily on GMP compliance and system validation. The professional will collaborate within an interdisciplinary project team dedicated to the modification and reconstruction of laboratory and cleanroom facilities. Key day-to-day responsibilities include the planning, execution, and comprehensive documentation of re-qualifications and change qualifications, specifically including Computer System Validations (CSV). A critical component of the job is ensuring that all equipment and utilities, such as compressed air and CO2 supply systems, meet current Good Manufacturing Practice (GMP) requirements following facility relocation or modification. This position requires a strong background in natural sciences or engineering, deep GMP knowledge, and proven practical experience in qualification activities (URS, RA, DQ), making it ideal for a detail-oriented professional seeking a challenging role in pharmaceutical compliance.
Required Skills
Education
Completed university degree in Natural Sciences, Biotechnology, Process Engineering, or comparable qualification
Experience
- Several years of practical experience as a Qualification Specialist in manufacturing GMP support
- Experience in qualification under GMP of devices, systems, or computer systems validation
Languages
Additional
- Not specified
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