Quality Assurance Expert | Biochemiker/in

Job Summary

This critical role involves managing quality aspects within the pharmaceutical manufacturing environment, ensuring all operative businesses strictly comply with cGMP, regulatory requirements, and the Novartis Quality Manual. The expert will provide GxP oversight across the site and act as the release responsible person, guaranteeing product quality and regulatory adherence. Key day-to-day responsibilities include reviewing and approving batch records (MBR/APQR), managing exceptions such as deviations and complaints, defining and implementing CAPAs, and collaborating on internal and external audits. The position requires a university degree in a relevant life science field (e.g., Biochemistry, Pharmacy), significant professional experience in the pharmaceutical industry, and at least two years dedicated to Quality Assurance. Candidates must possess thorough knowledge of cGMP and a proven track record working with major Health Authorities like the FDA and EMA. Fluent knowledge of both English and German is essential for success in this role, which offers worldwide career possibilities within the Novartis group.