GCP specialist R&D Auditing Department

20 ore fa

reggio emilia, Italia Chiesi Tempo pieno
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