Quality Assurance Expert | Quality Assurance (QA) Expert (m/w/d)

Job Summary

This Quality Assurance Expert role involves providing essential QA support for critical construction and implementation projects within a highly regulated GMP environment, focusing specifically on biopharmaceutical manufacturing, including cell and gene therapy facilities. Day-to-day responsibilities include the planning, execution, and comprehensive documentation of qualification activities (DQ, IQ, OQ, PQ) for cleanrooms, technical equipment, and production systems. The expert will be responsible for creating, reviewing, and approving key quality documents (URS, SOPs, validation plans), managing deviations, change controls, and CAPAs, and ensuring strict adherence to international regulatory standards (EU-GMP, FDA, ICH). This position offers the opportunity to drive innovation and continuous improvement in qualification processes at a leading BioTech firm dedicated to developing effective medical treatments. Candidates must possess a degree in a relevant field (Biotechnology, Engineering) and several years of QA/Validation experience in GMP settings, coupled with fluent German and English skills.