Senior GMP Audit & Compliance Manager

Darwinbox Digital Solutions Pvt. Ltd.; Bogotá ciudad; Presencial; COP 52.613.000 - 87.689.000; Jornada completa

Descripción de la vacante

Zydus Lifesciences is seeking a senior Corporate Quality Auditor to lead audits, ensure CAC/regulatory compliance, and support GMP inspections from its Corporate Quality Office in Ahmedabad. The role emphasizes audit planning, reporting, and cross-functional collaboration with site leadership.

Ideal candidates bring extensive experience in quality systems, regulatory guidance, and CAPA processes, with a proactive approach to continuous improvement and documentation control in a pharmaceutical

Formación

• Plan and execute audits to support CAC/regulatory requirements.
• Prepare and review audit agendas based on site performance.
• Ensure timely submission of audit reports and corrective actions.
• Assist sites during regulatory or GMP consultant inspections.
• Maintain regulatory document repository and portal status.
• Coordinate with Heads for audit outcomes and escalation.

Responsabilidades

• Plan and execute audits to support CAC/regulatory requirements.
• Prepare and review audit agendas based on site performance and expected regulatory inspection at site.
• Ensure execution of Corporate Quality Audit for quality systems as per SOP.
• Participate in audit opening and closing meetings and discuss observations with site leadership.
• Apprise audit outcomes to Head Technical Services, Head Central Quality and Head CAC prior to final report submission.
• Maintain repository of regulatory documents in portal and update status in management reviews.

Conocimientos

Audit management

Compliance

Regulatory knowledge

CAPA

Quality systems

SOP development

Stakeholder communication

Document control

Audit reporting

Regulatory inspections readiness

Herramientas

Audit portal

Descripción del empleo

Zydus Lifesciences is seeking a senior Corporate Quality Auditor to lead audits, ensure CAC/regulatory compliance, and support GMP inspections from its Corporate Quality Office in Ahmedabad. The role emphasizes audit planning, reporting, and cross-functional collaboration with site leadership.

Ideal candidates bring extensive experience in quality systems, regulatory guidance, and CAPA processes, with a proactive approach to continuous improvement and documentation control in a pharmaceutical