Corporate R&D Quality

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7etm40

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.
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 and 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 R&D;/QA GxP, within a pharma industry, CR

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7etm40