Corporate R&D Quality&Compliance Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c6ygd

Founded 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. 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 Computer System Validation projects within the Corporate R&D; Quality Management System.

Requirements:
- Bachelor's degree in the scientific field (e.g., Pharmacy, CTF, Biology, Biotechnology) and, preferably, Master’s degree.
- At least 1 year of experience in Quality management system in RD

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c6ygd