Corporate R&D Quality&Compliance Expert

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Corporate R&D; Quality&Compliance; ExpertApplyremote type: Site basedlocations: Abano Termetime type: Full timeposted on: Posted 2 Days Agojob requisition id: R-00074Founded in 1946, Fidia is an Italian multinational pharmaceutical company, with R&D;, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Eye Care, Skin Care, Specialty Care, Health&Wellness; Care.

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Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries.
Job Description
To strengthen our Corporate Clinical Safety, Pharmacovigilance and R&D; Compliance team, we are recruiting a
Corporate R&D; Quality & Compliance Expert
Main responsibilities:
* Support the development, maintenance, and revision of the Corporate R&D; Quality Management System,



including Corporate/Local SOPs and Working Instructions.
* Assist in the interpretation of GCP/GVP-related regulations (ICH, EU, FDA, etc.), translating them into company procedures and policies, and preparing the Quality Management Review.
* Provide GxP advice in cross-functional teams, supporting risk identification and risk-based Quality Management approaches.
* Support planning, conduction, and reporting of vendor audits, maintain Corporate Qualified Vendor Registries, and coordinate third-party audits and regulatory inspections, including inspection readiness and follow-ups.
* Oversee the implementation of CAPA Plans from inspections and audits, manage the Deviation monitoring system, support the performance of Root Cause Analysis, assess CAPAs, and ensure timely remediation of noncompliance.
* Assist in staff qualification, training activities, and maintaining relevant training documentation an support

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d5cph