full- or part-time, 74321 Bietigheim-Bissingen

Who we are

elderbrook is a comprehensive CRO specializing in biostatistics, clinical data sciences, and digital solutions for the pharmaceutical industry. Our team of experts provides tailored solutions, leveraging advanced technologies and methodologies.

Your responsibilities and functions

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

Your qualifications and competences

• 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

This is how you can reach us:

Please drop us a mail at:
jobs@elderbrook.de

We are looking forward to getting to know you!

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