GMP Deviation Investigator & CAPA Specialist

Novartis; Guamúchil; Hybrid; MXN 600,000 - 800,000; Full time

Job summary

Novartis in Mexico City is seeking a Quality Assurance Deviation Specialist to own investigations and ensure deviations are thoroughly analyzed and resolved in a complex GMP environment. You will collaborate with cross-functional teams to drive corrective actions while sustaining high quality standards and patient safety.

The role emphasizes structured root cause analysis, CAPA management, and robust documentation, with focus on training and continuous improvement across facilities and

Qualifications

• Bachelor’s degree in a relevant field with pharmaceutical industry experience.
• Fluency in written and spoken English.
• Two to five years of experience in a pharmaceutical, facilities, engineering, or quality environment.
• Hands-on experience with deviation management and writing investigations in a GMP environment.
• Proven experience in CAPA management, including creation, implementation, and effectiveness tracking.
• Strong root cause analysis skills using structured investigation methodologies.

Responsibilities

• Open and assess deviations within required timelines and document findings.
• Evaluate product impact of deviations against batch release standards.
• Lead investigations through to closure and update SOPs for Deviations/CAPAs.
• Apply root cause analysis to identify causes of process and product deviations.
• Ensure investigations are complete with robust documentation.
• Design and execute experiments to support investigation outcomes.
• Collaborate cross-functionally to assess deviation impact and maintain compliant operations.
• Develop, document, and implement effective corrective and preventive actions.
• Monitor CAPA effectiveness and ensure execution within GMP systems and training.

Skills

Business Processes

Data Analytics

Good Manufacturing Practices (GMP)

Resilience

Education

Bachelor’s degree in a relevant field

Job description

Novartis in Mexico City is seeking a Quality Assurance Deviation Specialist to own investigations and ensure deviations are thoroughly analyzed and resolved in a complex GMP environment. You will collaborate with cross-functional teams to drive corrective actions while sustaining high quality standards and patient safety.

The role emphasizes structured root cause analysis, CAPA management, and robust documentation, with focus on training and continuous improvement across facilities and