CAPA Excellence Lead – Quality & Compliance Strategy

IQVIA; Oeiras; Presencial; EUR 65 000 - 95 000; Tempo integral

Resumo da oferta

IQVIA in Portugal seeks a CAPA lead to drive corrective and preventive action management for significant quality issues and audit responses. You will assess investigations, perform root cause analyses, and implement effective actions with timely closure while promoting compliance with regulations and SOPs.

You will mentor the CAPA team, collaborate with cross-functional stakeholders, document actions in the eQMS, and support internal and external audits to maintain inspection readiness.

Qualificações

• Experience with CAPA management and quality systems.
• Experience in audits and inspections.
• Strong root cause analysis and problem solving.

Responsabilidades

• Lead and mentor the CAPA management team to drive improvement and compliance.
• Lead CAPA activities for complex QIs and sponsor audits/inspections with timely actions.
• Collaborate with cross-functional stakeholders to identify gaps and ensure QMS alignment.
• Ensure CAPA reporting and documentation in the eQMS with timely closures.
• Promote proactive process improvement by identifying risks and trends.
• Provide training on RCA, CAPA management, and compliant documentation.

Conhecimentos

CAPA knowledge

GCP guidelines

Quality investigations

Root cause analysis

Leadership

Formação académica

Bachelor's Degree

Ferramentas

Microsoft Office (Word, Excel)

eQMS systems

Descrição da oferta de emprego

IQVIA in Portugal seeks a CAPA lead to drive corrective and preventive action management for significant quality issues and audit responses. You will assess investigations, perform root cause analyses, and implement effective actions with timely closure while promoting compliance with regulations and SOPs.

You will mentor the CAPA team, collaborate with cross-functional stakeholders, document actions in the eQMS, and support internal and external audits to maintain inspection readiness.