Informationen zur Anzeige:
Quality Assistant 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 Assistant GCP (m/w/d) full- or part-time (from 20 hours/week) - mainly remote
Aufgaben:
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
Qualifikationen:
Soft-Skills: Kommunikationsfähigkeit, Selbständiges Arbeiten, Problemlösefähigkeit, Sorgfalt/Genauigkeit, Teamfähigkeit
- 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
Standorte