Senior Clinical QA Auditor: GCP Compliance & Audits

IQVIA; Madrid; Presencial; EUR 65.000 - 95.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an experienced QA Auditor to plan and conduct independent clinical (GCP) audits across European sites as part of IQVIA contracts. You will assess compliance with regulations, guidelines, and SOPs, and report findings to supervisors, management and customers.

The role requires 5 years in pharmaceutical QA/audits, Italy audit certification, and willingness to travel 30–50% mainly across Europe; strong analytical and communication skills are essential to propose corrective actions

Formación

• Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
• 5 years experience in pharmaceutical or related area, with 3 years in Quality Assurance Audits.
• Experience in clinical trial Investigator site audits is preferred.
• Knowledge of QA processes and regulatory environments.

Responsabilidades

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts to assess compliance with regulations/guidelines and SOPs.
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations, compliance status, and procedures.

Conocimientos

Interpersonal skills

Problem solving

Training capabilities

Organizational skills

Communication

Educación

Audit certification Italy (Decree)

Herramientas

Word processing

Spreadsheet

Database applications

Descripción del empleo

IQVIA is seeking an experienced QA Auditor to plan and conduct independent clinical (GCP) audits across European sites as part of IQVIA contracts. You will assess compliance with regulations, guidelines, and SOPs, and report findings to supervisors, management and customers.

The role requires 5 years in pharmaceutical QA/audits, Italy audit certification, and willingness to travel 30–50% mainly across Europe; strong analytical and communication skills are essential to propose corrective actions