Description
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
– Degree in healthcare or natural science or qualification in a related field preferable
– Basic experience in clinical research and/or GxP environment preferable
– Basic knowledge of GCP principles and understanding of relevant international and national regulations and regulatory requirements preferable (e.g. GCP, GMP, FDA CFR 21 and/or related standards like ISO 9001, ISO 13485)
– Basic experience in document management
– Fluent in written and spoken German and English
– Confident in handling all MS Office applications
Ergänzende Informationen:
Anforderungen an den Bewerber:
Grundkenntnisse: Qualitätsaudit, Projektmanagement
Erweiterte Kenntnisse: Medizinische Dokumentation, Berichtswesen, Information, Qualitätsentwicklung, Qualitätsmanagement
Expertenkenntnisse: Internationale pharmazeutische Standards (z.B. GLP, GMP)