Assistance and support of the QA Team in the following areas: - Maintenance, monitoring and continuous improvement of the internal quality management system (QMS) with consideration of all GCP aspects and regulations - Creation, maintenance and monitoring of QM documents (including SOPs) - Preparation and follow-up of internal audits and CAPAs - Fostering general awareness and adherence to company SOPs and guidelines - Preparation and follow up of supplier selections & qualifications - Compilation and evaluation of key performance indicators - Coordination and oversight of the onboarding process for new hires to ensure competency in job functions - Ensuring adequate training and adherence to company SOPs and guidelines - Organization, oversight and tracking of training attendance, performance and completion as well as evaluation of effectiveness - Maintenance of up-to-date qualification evidence for all employees working in a GxP environment