Quality Assurance Expert - Sterile Manufacturing | Quality Assurance Expert - Sterile Manufacturing (all genders)

Job Summary

As a Quality Assurance Expert, you will be a key member of the Site Quality Darmstadt Development team, supporting the launch and routine manufacturing of parenteral products for clinical studies at the Technical Development Center. Your daily responsibilities will include overseeing GMP processes, reviewing and approving SOPs, performing batch record reviews, and preparing product documentation for release. You will also act as shop floor QA, manage deviations and change controls, and ensure compliance with regulatory requirements and quality standards. This role involves supporting internal and global quality interfaces, as well as assisting with site audits and inspections. The ideal candidate will possess a strong scientific background, extensive experience in pharmaceutical GMP manufacturing of sterile products, and excellent communication skills to thrive in a dynamic, patient-focused environment.