Corporate R&D Quality&Compliance Expert

12 ago - Giarre
Fidia Pharma

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. 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 DescriptionTo strengthen our Corporate Clinical Safety, Pharmacovigilance and R&D; Compliance team, we are recruiting aCorporate R&D; Quality & Compliance ExpertMain 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 fiel

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