GCP specialist R&D Auditing Department

15 ott - Parma
Chiesi

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. Retribuzione / Benefits * pension * private medical insurance * wellbeing programme * flexible benefits programme * remote work options * relocation support Responsabilità * 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 Requisiti fondamentali * 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 * Clear communicator * Attention to detail * Team collaboration * GCP knowledge * Quality system proficiency * CAPA management

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