Quality Assurance Specialist - QMS F - M H/F Astek

Alsinova, the Astek Group subsidiary offering a complete CRO solution, is recruiting a Senior Preclinical Biostatistician for a project in the pharmaceutical sector.
Your mission (should you decide to accept it):

Reporting to the Quality Manager and working closely with cross-functional teams, you will support and develop QMS processes in compliance with applicable regulations (GxP, ISO standards, etc.).

You'll contribute to the continuous improvement of the quality system and ensure proper implementation across departments and projects.

Your daily activities will be:

- Ensure the proper deployment and maintenance of the Quality Management System
- Write, update, and manage quality documentation: procedures, instructions, forms
- Organize and follow-up on internal and external audits
- Manage deviations, CAPAs and change control processes
- Monitor and report quality indicators and KPIs
- Contribute to training plans and awareness campaigns on quality standards
- Support qualification and validation activities (equipment, processes, suppliers)
- Ensure compliance with applicable regulatory frameworks (GMP, ISO 9001/13485...)
- Participate in the continuous improvement of the system

Your future team:

You'll be part of a motivated and quality-driven environment that encourages initiative, process optimization and proactive collaboration.

You'll benefit from technical support, cross-functional exposure, and career development opportunities within a fast-growing organization.