Senior Global GMP Quality Auditor | Travel 60%

Novartis; Madrid; Presencial; EUR 69.000 - 128.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation support

Hybrid working options

Wellbeing resources

Descripción de la vacante

Novartis is seeking a Global GMP Senior Quality Auditor who will travel up to 60% and base in Spain (Madrid or Barcelona) or Slovenia (Ljubljana). You will lead, support and report on internal and external GMP audits to ensure compliance with the Novartis Quality System and current GMP regulations.

Responsibilities include planning and executing audits, mentoring junior auditors, providing regulatory guidance, and developing CAPA responses with QA stakeholders.

Formación

• 12+ years of experience in Pharmaceutical or Medical Device industries.
• 3 years auditing experience preferred with strong regulatory knowledge.
• Fluent in English, both written and spoken.

Responsabilidades

• Plan, lead, conduct GMP audits according to Novartis Quality procedures and applicable regulations.
• Review corrective action plans and follow up on audit observations.
• Provide regulatory guidance for timely remediation and recommendations regarding filing acceptability.
• Mentor junior GMP staff and act as GMP training consultant as needed.
• Escalate critical findings to management and define mitigation actions with QA.
• Assess the adequacy of CAPA responses in cooperation with QA and Auditees.

Conocimientos

GMP auditing

Regulatory compliance

Risk assessment

Stakeholder management

English fluency

Descripción del empleo

Novartis is seeking a Global GMP Senior Quality Auditor who will travel up to 60% and base in Spain (Madrid or Barcelona) or Slovenia (Ljubljana). You will lead, support and report on internal and external GMP audits to ensure compliance with the Novartis Quality System and current GMP regulations.

Responsibilities include planning and executing audits, mentoring junior auditors, providing regulatory guidance, and developing CAPA responses with QA stakeholders.