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Department: Global Quality Systems and Compliance
Position Overview: We are seeking a motivated and dynamic individual to join our Global Quality Systems and Compliance. The candidate will collaborate to ensure that clinical trials sponsored by Kedrion are conducted in compliance with with current regulations and company quality standards.
Key Responsibilities:
• 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.
Requirements:
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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