Quality Engineer, Pharmaceutical Biotechnology | Qualitätsingenieur Phamazie Biotechnologie (m/w/d)

Job Summary

This role is ideal for a professional seeking challenging projects in the medical technology sector, focusing specifically on quality assurance within pharmaceutical biotechnology. The Quality Engineer will be responsible for managing deviations and change controls related to the manufacturing, testing, and storage of cell banks, drug substances, and drug products for internal development projects. Key daily tasks include representing the quality department in team rooms concerning deviations and change controls, creating Product Specification Files, and serving as the primary quality contact for manufacturing and quality units. Candidates must possess a degree in Medical Technology or Biology, coupled with initial experience in manufacturing or testing biological active ingredients/products. Essential qualifications include knowledge of GMP regulations and quality processes like Deviation, Investigation, and CAPA, making this a pivotal role in ensuring product quality and regulatory compliance.