Senior Clinical QA Auditor — GCP Compliance & Audit Lead

IQVIA; Oeiras; Presencial; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

IQVIA is seeking an experienced Quality Assurance Auditor to plan and conduct independent GCP audits across Europe, ensuring compliance with regulations, guidelines, and IQVIA SOPs. You will prepare findings reports for supervisors, operations staff, management, and customers, and provide interpretation of regulations and policies.

You will review and approve investigations, RCA, CAPA, and EC plans, and support QA initiatives and training for staff.

Qualificações

• Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
• Travel 30-50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Experienced in the conduct of clinical trial Investigator site audits.
• Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.

Responsabilidades

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts to assess compliance with regulations and guidelines.
• Evaluate audit findings and prepare/distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations and policies.
• Formulate corrective action plans with customers and monitors.
• Review and track CAPA/EC plans to closure for quality events.
• Support management with continuous process improvements.

Conhecimentos

Quality Assurance Audits

Regulatory Compliance

Audit Planning

GCP Awareness

Interpersonal Skills

Formação académica

Auditing Certification (Italy)

Bachelor's degree in Life Sciences

Ferramentas

Word Processing

Spreadsheet

Database Applications

Descrição da oferta de emprego

IQVIA is seeking an experienced Quality Assurance Auditor to plan and conduct independent GCP audits across Europe, ensuring compliance with regulations, guidelines, and IQVIA SOPs. You will prepare findings reports for supervisors, operations staff, management, and customers, and provide interpretation of regulations and policies.

You will review and approve investigations, RCA, CAPA, and EC plans, and support QA initiatives and training for staff.