Validation & Qualification Expert – Analytical Methods & GMP – Biopharma | Validation & Qualification Expert (m/w/d) – Analytische Methoden & GMP – Biopharma
expertum GmbH - Niederlassung Biberach
Job Summary
This role involves ensuring the quality and compliance of biopharmaceutical products by performing qualifications of complex computerized analytical systems according to BI LeVa principles. A key part of the job is planning, developing, validating, and verifying analytical methods for quality control, with a strong focus on physicochemical methods like pH, osmolality, conductivity, and particle testing. The expert will also contribute to the development and implementation of new analytical techniques within a GMP environment, support laboratory management, and handle tasks related to the Quality Management System. This position offers a chance to join a reputable company in the chemistry/pharmaceutical sector, leveraging extensive experience in analytical systems and method validation.
Required Skills
Education
Master's or Bachelor's degree in Biology, Biopharmacy, Biotechnology, Biochemistry, or Chemistry, or a scientific education with many years of relevant experience.
Experience
- Several years of practical experience in qualifying analytical systems
- Several years of practical experience in validating/verifying analytical methods
- Experience in troubleshooting analytical issues
- Experience in a GMP environment
- Knowledge in virology is a plus
Languages
Additional
- Not specified
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