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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

Quality Assistant GCP (m/w/d) full- or part-time (from 20 hours­­/­­week) - mainly remote

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elderbrook solutions GmbH
Bietigheim-Bissingen (DE)
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