About Meridian
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary
The role of RA/QA Documentation Specialist-PR (Person Responsible for Good Distribution Practice) is a pillar in the RA/QA team of the entire Company. The RA/QA Documentation Specialist-PR is expected to provide significant support in the maintenance and the development of documents, procedures and record changes to existing procedures, processes, plans, and other quality systems and regulatory documentation according to the quality and regulatory requirements. The Person Responsible (PR) ensures that all distribution activities are carried out in compliance with Good Distribution Practice (GDP).
Key Duties
1. Contribute to the maintenance and continuous improvement of the company's Quality Management System (QMS)
2. Develop, update, and control quality documentation for IVD/MD devices and pharmaceuticals
3. Maintain technical files supporting CE-marked IVD/MD devices
4. Support regulatory documentation and registration processes in EMEA and APAC regions
5. Ensure complete and traceable documentation for audits, reports, and performance monitoring
6. Manage and support processes related to Change Control, CAPA, and Post-Market Surveillance (including vigilance and pharmacovigilance)
7. Ensure compliance with Good Distribution Practice (GDP) throughout the distribution process
8. Cooperate with internal and external stakeholders to maintain product traceability and quality standards
9. Participate actively in internal and external audits
Qualifications
* Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry and Technology, or Industrial Chemistry
* 3–5 years of experience in Quality Assurance & Regulatory Affairs and pharmaceutical distribution
* Knowledge of ISO 13485, IVDR/MDR, GDP, and Italian pharmaceutical regulations
* Highly motivated, organized, and detail-oriented
* Strong analytical, problem-solving, and communication skills
* Autonomous, flexible, and collaborative across multicultural teams
* Skilled in managing multiple priorities and meeting deadlines
* Proficient in English (verbal and written) and Microsoft Office
* Strong sense of responsibility and commitment to quality