Documentation Specialist | Document Assistant (m/w/d), Herbert-Bayer-Straße 8

Job Summary

This role is crucial for maintaining quality standards within an internationally operating BioTech company specializing in biopharmaceutical development and manufacturing in Berlin. The Documentation Specialist will be responsible for the comprehensive management of quality documents, including the creation, editing, and review of critical documentation such as CAPA, CCO, and maintenance reports, strictly adhering to SOP guidelines. A major focus involves leading the coordination and release of qualification documents (DQ, IQ, OQ, PQ) for technical systems and premises, requiring expertise in validation concepts and the GMP guideline. The ideal candidate holds a degree in Pharmaceutical Technology, Biotechnology, or a related technical field, coupled with initial professional experience in a GMP environment. Success in this position requires business-fluent German and good English skills, strong written communication, and proficiency with digital tools like Microsoft Office. This is an opportunity to contribute directly to groundbreaking innovations in medical therapies within a supportive and growing team culture.