GxP Compliance & Audit Specialist — CSV & Quality Systems

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

Descripción de la vacante

Novartis México is seeking an Audit and Compliance Specialist responsible for ensuring compliance and Quality Assurance support of GxP computerized systems, including supplier quality management throughout their lifecycles. The role also involves reviewing and approving key quality activities and ensuring alignment with internal regulations.

The candidate should have a degree in chemistry, biology, or related fields, with a minimum of three years of relevant experience. Fluent English is a must, and Spanish is desirable.

The position offers opportunities for professional growth and a comprehensive benefits package.

Formación

• Minimum 3 years of overall automation/CSV experience, or a minimum of 3 years in a laboratory setting.
• Excellent knowledge of Microsoft Office is required.
• Fluent English, written and spoken; Spanish is desirable.

Responsabilidades

• Ensure all site activities comply with cGxP, regulatory requirements, company quality standards, and data integrity expectations.
• Plan, support, review, and approve key quality activities including PQR/APQR, validation, and qualifications.
• Support audit and inspection readiness, including preparation and communication with stakeholders.

Conocimientos

Strong drive to learn

Commitment to accuracy

Excellent communication skills

Solid quality experience in inspections and audits

Excellent knowledge of Microsoft Office

Fluent English (written and spoken)

Spanish (desirable)

Educación

Degree in chemistry, biology, computer science, or life sciences

Descripción del empleo

Novartis México is seeking an Audit and Compliance Specialist responsible for ensuring compliance and Quality Assurance support of GxP computerized systems, including supplier quality management throughout their lifecycles. The role also involves reviewing and approving key quality activities and ensuring alignment with internal regulations.

The candidate should have a degree in chemistry, biology, or related fields, with a minimum of three years of relevant experience. Fluent English is a must, and Spanish is desirable.

The position offers opportunities for professional growth and a comprehensive benefits package.