**Summary**:
The Audit and Compliance Specialist is responsible for the compliance and Quality Assurance support of the GxP computerized systems including supplier quality assessment/management throughout their lifecycles in regards to the applicable regulations and requirements defined in the Novartis Quality Manual and procedures.
eCompliance provides guidance on CSV related topics and related information.
- Reviews and/or approves the qualification and operational deliverables of respective GxP computerized systems.
Managing work in accordance with the law, internal regulations, good practices and business objectives.
**About the Role**:
**Major Accountabilities**:
- 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, qualification, change controls, CAPAs, deviations, and follow-up actions.
- Implement and maintain Quality Systems, including documentation management, process quality assurance, KPI trending, and continuous improvement initiatives.
- Provide quality oversight for GxP computerized systems, including classification, qualification, supplier assessment, lifecycle management, risk mitigation, and review/approval of related documentation.
- Support audit and inspection readiness, including preparation, coordination, participation, follow-up, and communication with internal and external stakeholders.
- Manage supplier quality activities, including quality agreements,



oversight, audits, and ensuring compliance with applicable Novartis and regulatory requirements.
- Comply with HSE requirements, participate in risk assessments and audits, report potential risks, complete required training, and contribute to personal development while representing the company's values.
**Obligatory requirements**:
- Education: Degree in chemistry, biology, computer science, life sciences
- Minimum 3 years of overall automation/CSV experience, or a minimum of 3 years of Laboratory.
- Strong drive to learn, a commitment to accuracy and excellent communication skills.
- Solid quality experience in inspections and audits as essential to maintaining high standards and ensuring compliance.
- Excellent knowledge of Microsoft Office
- Fluent English, written and spoken.
Spanish is desirable.
**Commitment to Diversity and Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
**Benefits and Rewards**: Learn about all the ways we'll help you thrive personally and professionally.
- Read our handbook (PDF 30 MB)
Division
Operations
Business Unit
Production / Manufacturing
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:

📌 Audit And Compliance Specialist (Xico)
🏢 Novartis
📍 Xico