GCP specialist R&D Auditing Department

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

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