Senior QA Auditor – GxP Compliance & Risk Lead

Ergomed; Roma; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Ergomed is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across the company and its clients. The role requires deep GxP expertise, experience in QA auditing, and strong communication to drive risk-based audit planning.

You will conduct diverse audit types, from internal system audits to vendor audits, and support QA activities including CAPA management, training, and procedures updates. Fluency in English is essential, with local language skills a plus.

Qualifications

• Bachelor's degree in a science field is required; master's preferred.
• Strong experience in pharmaceutical/biotech pharmacovigilance and QA auditing.
• Fluent English, written and spoken; other languages a plus.

Responsabilités

• Lead internal and contracted audits per Audit Program.
• Prepare and report audit findings and CAPA plans.
• Act as QA contact for designated clients and audits.
• Contribute to audit strategy and risk-based planning.

Connaissances

GxP auditing

Quality Assurance

Auditing

Regulatory knowledge

Formation

Bachelor in scientific discipline

Outils

Audit software

Description du poste

Ergomed is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across the company and its clients. The role requires deep GxP expertise, experience in QA auditing, and strong communication to drive risk-based audit planning.

You will conduct diverse audit types, from internal system audits to vendor audits, and support QA activities including CAPA management, training, and procedures updates. Fluency in English is essential, with local language skills a plus.