Intern - Abano Terme, Italia - Fidia Farmaceutici

Fidia Farmaceutici

Azienda verificata

Abano Terme, Italia

4 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

With the aim of strengthening the Corporate structure, in line with the Company Vision and the International Company development plans, we are looking for a:

R&D Quality Management System

Intern
to join the Corporate Clinical Safety, Pharmacovigilance and Compliance R&D.

In this role you will have the opportunity to:

Supporting the Corporate R&D Q&C Specialist and actively cooperate in the development and maintenance of the Corporate R&D QMS at Fidia Farmaceutici S.p.

A. and its Subsidiaries across EU and extra-EU regions

Ensuring compliance to all the applicable legal and regulatory requirements, and in particular to GCP for Medicinal Products and Medical Devices and GVP for Medicinal Products for Human and Veterinary use.

Main Responsibilities:

Supporting the development and maintenance of the overall Corporate R&D Quality Management System for Pre-Clinical and Clinical research, Pharmacovigilance System, Medical Affairs
Participating in crossfunctional teams where the Corporate R&D Compliance Specialist provides GxP advice and guidance on risk identification and riskbased approach in Quality Management
Maintaining the Corporate Qualified Vendor Registry
Supporting the managing of the Deviation monitoring system to ensure timely remediation of noncompliance, including the performance of any needed Root Cause Analysis, evaluation of suggested CAPAs and assessment of their effectiveness
Collaborating in the development of internal GxP training programs and maintaining training documentation.

Requirements:

Specialization in Pharma Regulatory Affairs, GxP Quality Systems, Clinical Research, Pharmacovigilance
Good knowledge of computer systems, i.e. Microsoft, Word, Excel & PowerPoint
Good eye for details, ability to analyzing challenging concepts, team working oriented, precision, organization and problemsolving skills
Fluent in English.

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Location:Abano Terme (PD)