Informationen zur Anzeige:
Quality Manager GCP (m/w/d) full- or part-time (from 20 hours/week) - mainly remote
elderbrook solutions GmbH
Bietigheim-Bissingen (DE)
Aktualität: 22.10.2024
Anzeigeninhalt:
22.10.2024, elderbrook solutions GmbH
Bietigheim-Bissingen (DE)
Quality Manager GCP (m/w/d) full- or part-time (from 20 hours/week) - mainly remote
Aufgaben:
- 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
Qualifikationen:
- 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
Standorte