GxP Compliance & Quality Assurance Specialist

Novartis; México; Presencial; MXN 600.000 - 800.000; Jornada completa

Descripción de la vacante

Novartis is seeking an Audit and Compliance Specialist in Mexico to support compliance and Quality Assurance of GxP computerized systems throughout their lifecycles. You will provide guidance on CSV topics and ensure regulatory and quality standards are met.

Responsibilities include planning and approving validation, qualification, CAPAs, deviations, and supplier quality activities, with focus on data integrity and risk mitigation. Fluency in English is required; Spanish desirable.

Formación

• Degree in chemistry, biology, computer science or life sciences.
• Minimum 3 years of automation/CSV experience or 3 years in a Laboratory.
• Fluent English (written and spoken); Spanish desirable.
• Solid quality experience in inspections and audits to maintain high standards and compliance.

Responsabilidades

• Ensure all site activities comply with cGxP, regulatory requirements, quality standards and data integrity expectations.
• Plan, support, review, and approve key quality activities like PQR/APQR, validation, qualification, change controls, CAPAs, deviations and follow-ups.
• Implement and maintain quality systems including documentation management, KPI tracking and continuous improvement.
• Provide quality oversight for GxP computerized systems including classification, qualification, supplier assessment and lifecycle management.
• Support audit and inspection readiness: preparation, coordination, participation, follow-up, and stakeholder communication.
• Manage supplier quality activities including quality agreements, oversight and audits to ensure regulatory compliance.
• Act as a key contact for Health Authorities and internal compliance partners, ensuring communication and regulatory submissions as required.
• Comply with HSE requirements, participate in risk assessments and audits, report risks and contribute to personal development.

Conocimientos

Quality Assurance

Regulatory knowledge

GxP compliance

English proficiency

Educación

Bachelor's degree in Chemistry, Biology, Computer Science or Life Sciences

Herramientas

Microsoft Office

Descripción del empleo

Novartis is seeking an Audit and Compliance Specialist in Mexico to support compliance and Quality Assurance of GxP computerized systems throughout their lifecycles. You will provide guidance on CSV topics and ensure regulatory and quality standards are met.

Responsibilities include planning and approving validation, qualification, CAPAs, deviations, and supplier quality activities, with focus on data integrity and risk mitigation. Fluency in English is required; Spanish desirable.