Description
– 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)
– Support with external audits and official inspections
– Preparation and implementation of internal audits
– Planning, tracking and monitoring the effectiveness of corrections (CAPA)
– Monitoring mandatory training and compliance with the company’s SOPs and guidelines
– Risk management for projects and coordination of suitable measures
– Collaboration with department heads and support in determining training needs
– Developing an annual training plan and individual training programs
– Maintaining and managing the current qualification certificates for all employees in the GCP area
– Completed scientific studies or qualification in healthcare or a related field
– Several years of practical experience in regulated quality management (with a focus on clinical quality management or clinical research)
– Very good knowledge of GCP principles and in-depth knowledge of all relevant international and national regulations and legal requirements (e.g. ICH Guidelines, Clinical Trial Regulation, ISO 9001, FDA CFR 21)
– Experience in document management
– Fluent in written and spoken German and English
– Strong communication skills and professional, goal-oriented cooperation with various departments
– Moderation of meetings and presentations
– Confident in handling all MS Office applications