GMP Deviation Investigator & CAPA Lead

Novartis; Ciudad de México; Hybrid; MXN 900,000 - 1,300,000; Full time

Job summary

Novartis in Mexico City is seeking a quality-focused investigator to own deviation investigations in a GMP environment. You will drive root cause analyses and corrective actions, ensuring full regulatory alignment and robust documentation.

The role requires a pharma background, English fluency, and 2–5 years of related experience. You will work cross-functionally to maintain high quality standards and continuous improvement.

Qualifications

• Bachelor's degree in a pharmaceutical/related field required.
• Fluent in written and spoken English.
• 2–5 years in pharma, facilities, engineering, or quality environment.
• Hands-on deviation management and investigations in GMP.
• Strong CAPA management and effectiveness tracking.

Responsibilities

• Open and assess deviations within required timelines with proper documentation.
• Evaluate product impact and align with batch release standards.
• Lead investigations from start to closure; update SOPs for deviations/CAPAs.
• Apply root cause analysis to identify process and product deviation causes.
• Ensure investigations have robust documentation and are fully supported.
• Design and execute experiments to support investigation outcomes.
• Collaborate cross-functionally to assess deviation impact and compliance.
• Develop, document, and implement effective corrective actions.
• Monitor CAPA effectiveness and ensure GMP-compliant training.

Skills

Root cause analysis

CAPA management

GMP knowledge

Investigations writing

Education

Bachelor's degree in pharmaceutical field

Job description

Novartis in Mexico City is seeking a quality-focused investigator to own deviation investigations in a GMP environment. You will drive root cause analyses and corrective actions, ensuring full regulatory alignment and robust documentation.

The role requires a pharma background, English fluency, and 2–5 years of related experience. You will work cross-functionally to maintain high quality standards and continuous improvement.