25 km
elderbrook solutions GmbH
Quality Manager GCP (m/w/d) full- or part-time (from 20 hours­­/­­week) - mainly remote 22.10.2024 elderbrook solutions GmbH Bietigheim-Bissingen (DE)
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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

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