GCP QA Specialist – Audits & Compliance (Hybrid Milan)

PHIDEALIVE Srl; Milano; Ibrido; EUR 60.000 - 85.000; Tempo pieno

Descrizione del lavoro

Phidealive S.r.l. is seeking an experienced Quality Assurance professional with strong GCP expertise to oversee the Quality Management System and ensure compliant clinical activities. The role involves audits, CAPAs, and training across the study lifecycle, with English and Italian proficiency in a hybrid Milan-based setting.

The candidate will collaborate with Clinical Operations to maintain inspection readiness and uphold regulatory standards within CRO/Pharma environments.

Competenze

• Minimum 5 years in clinical research within CRO/pharma/biotech/medical devices.
• Demonstrated GCP quality assurance experience.
• Strong ICH-GCP and EU 536/2014 knowledge.
• Experience planning, conducting GCP audits.
• Ability to assess compliance risks and guide teams.
• Excellent English and Italian communication.

Mansioni

• Maintain and improve the Quality Management System (QMS).
• Plan, conduct, and report internal, vendor, investigator site, and study audits.
• Review trial documentation for quality and compliance.
• Manage audit findings, deviations, CAPAs and root-cause analyses.
• Support inspection readiness.
• Provide quality oversight across the study lifecycle.
• Advise on GCP compliance to Clinical Operations.
• Contribute to GCP training for staff.

Conoscenze

GCP compliance

Audit planning

QMS management

Regulatory knowledge

Bilingual EN-IT

Formazione

Life sciences degree

Descrizione del lavoro

Phidealive S.r.l. is seeking an experienced Quality Assurance professional with strong GCP expertise to oversee the Quality Management System and ensure compliant clinical activities. The role involves audits, CAPAs, and training across the study lifecycle, with English and Italian proficiency in a hybrid Milan-based setting.

The candidate will collaborate with Clinical Operations to maintain inspection readiness and uphold regulatory standards within CRO/Pharma environments.