Experteer Overview In this role you ensure GCP compliance across Global R&D; by managing CAPAs, quality metrics, and audit programs. You will drive the documentation and process controls that support audit readiness and supplier qualification. You work closely with cross-functional teams to sustain a robust quality system and enable compliant clinical trials. The position offers a hybrid setup at the Parma HQ within a values-driven, sustainability-minded organization. Responsibilities Manage GCP CAPA plans and follow-up Coordinate collection of quality metrics and KPIs for Global R&D; Oversee Trackwise, supplier,



and audit workflows Support external consultants in the Auditing & Supplier Qualification Unit Finalize Quality Documents for the unit Write/Review SOPs related to audit and qualification of clinical service providers Provide training on relevant activities and procedures Ensure documentation traceability and audit report finalization Qualifications At least 3 years of experience in Pharmaceutical, Consultancy, or CRO in Quality Assurance for R&D; with strong GCP knowledge Knowledge of GCP requirements and quality systems Understanding of the pharmaceutical development process supporting clinical trials Experience with training techniques Scientific degree Good knowledge of English Benefits pension private medical insurance wellbeing programme flexible benefits programme remote work options relocation support #J-18808-Ljbffr

📌 Gcp specialist r&d auditing department (Italia)
🏢 Experteer Italy
📍 Italia