At Hartwig Medical Foundation (Hartwig), we are dedicated to improving care for patients with cancer through high-quality genomic diagnostics and data. Quality, reliability, and compliance are at the heart of everything we do.To strengthen our Quality team, Hartwig is looking for an experienced Validation Specialist. In this role, you will be responsible for developing and overseeing validation activities across the organization. You will ensure that validation projects comply with applicable regulations and quality standards while supporting colleagues in maintaining an efficient and compliant validation process.
What you will do
As our Validation Specialist, you will play a key role in ensuring that our validation processes meet the highest quality and regulatory standards. Your responsibilities will include:
- Developing, implementing and maintaining validation workflows in accordance with applicable regulations and quality standards.
- Monitoring and supporting verification and validation projects from a regulatory and quality perspective.
- Reviewing and approving verification and validation reports to ensure compliance with regulatory requirements and clinical standards.
- Training and supporting colleagues involved in verification and validation activities on established workflows, procedures and guidelines.
- Keeping up to date with changes in relevant regulations and translating these into our quality processes.
- Supporting broader Quality Management System (QMS) activities, including document control, change management and other quality-related processes.
