GxP Compliance & Quality Assurance Specialist

Biopharma Careers; Ciudad de México; Presencial; MXN 480.000 - 620.000; Jornada completa

Descripción de la vacante

Novartis is seeking an Audit and Compliance Specialist to support GxP computerized systems and supplier quality management across their lifecycles. The role focuses on regulatory compliance, data integrity, and quality assurance in alignment with the Novartis Quality Manual.

The candidate will review and approve qualification deliverables, support audits, and maintain quality systems while ensuring adherence to internal regulations and business objectives.

Formación

• Education: Degree in chemistry, biology, computer science, or life sciences.
• Minimum 3 years of automation/CSV experience, or 3 years in a Laboratory.
• Fluent written and spoken English; Spanish desirable.
• Solid quality experience in inspections and audits to ensure compliance.
• Excellent knowledge of Microsoft Office.

Responsabilidades

• Ensure site activities comply with cGxP, regulatory requirements and data integrity standards.
• Plan, review, and approve quality activities including PQR/APQR, validation, change controls and CAPAs.
• Maintain Quality Systems, documentation management, KPI trends, and continuous improvement.
• Provide quality oversight for GxP computerized systems and supplier lifecycle management.
• Support audit and inspection readiness, including coordination with stakeholders.
• Manage supplier quality activities, audits, and compliance with regulatory requirements.
• Act as a point of contact for Health Authorities and compliance partners; manage certificates and submissions.
• Comply with HSE requirements and participate in risk assessments and training.

Conocimientos

Quality assurance

Regulatory compliance

GxP

CSV

Audits

Data integrity

Communication

Microsoft Office

Educación

Degree in chemistry

Degree in biology

Degree in computer science

Degree in life sciences

Herramientas

Microsoft Office

Descripción del empleo

Novartis is seeking an Audit and Compliance Specialist to support GxP computerized systems and supplier quality management across their lifecycles. The role focuses on regulatory compliance, data integrity, and quality assurance in alignment with the Novartis Quality Manual.

The candidate will review and approve qualification deliverables, support audits, and maintain quality systems while ensuring adherence to internal regulations and business objectives.