At Kedrion, we believe that innovation and care must go hand in hand. Our mission is to enhance lives through our dedicated work in the field of rare and ultra-rare diseases.
As a global leader with a passionate team of 5,400 employees, we collect and fractionate plasma to produce and distribute 38 vital medicines worldwide, establishing ourselves as the fifth largest player in the plasma-derived products sector.
Job Summary
We are seeking a motivated and dynamic individual to join our Global Quality Systems and Compliance team. The candidate will collaborate to ensure that clinical trials sponsored by Kedrion are conducted in compliance with current regulations and company quality standards.
What you'll do
- Collaborates in the implementation and maintenance of the Quality System for the clinical trials area.
- Participates in the process of managing changes that impact clinical trials.
- Takes part in the internal and external verification process in the clinical field as an Auditor.
- Contributes to identifying possible deviations from the GCP system and collaborates in the process of managing deviations and CAPAs.
- Participates in the analysis of trends in GCP processes.
- Collaborates in the review of Preclinical and Clinical Protocols and Reports.
- Participates in the process of preparing the Study Risk Assessment in the GCP area.
- Collaborates in the process of managing the training of personnel involved in activities related to clinical trials.
- Participates in the process of qualifying suppliers in the GCP area.
- Drafts and reviews Standard Operating Procedures for which the function is responsible.
- Carries out its activities in compliance with Best Practices and regulatory provisions applicable to the clinical trials sector.
- Collaborates in monitoring the production activities of experimental products (planning, packaging, storage and shipping) to ensure compliance with current regulations and company quality standards.
- Verifies that all documents managed by the Information System are aligned with the provisions of the document management procedure.
Qualifications and need‑to‑know
- Scientific Bachelor's degree
- Interest in the Quality and Compliance field.
- Good analytical skills, strong attention to detail, accuracy, flexibility.
- Excellent communication skills and the ability to work in a team.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Good knowledge of English (written and spoken).
This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).
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