Facilities Deviation Writer

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

Job Description Summary

#LI-Hybrid

Location: Mexico City, Mexico

Relocation Support: This role is based in Mexico City, Mexico. Novartis is unable to offer relocation support: please only apply if accessible.

Take ownership of quality where it truly matters - at the intersection of facilities, engineering, and patient impact. In this role, you will play a key part in ensuring deviations are thoroughly investigated, understood, and resolved, helping to maintain high standards in a complex GMP environment. You'll work closely with cross-functional teams to drive robust investigations and meaningful corrective actions, while shaping a culture of continuous improvement and quality excellence. If you enjoy combining analytical thinking with hands‑on collaboration, this role offers a chance to make a real difference.

Job Description

Key Responsibilities

• Open and assess deviations within required timelines, ensuring accurate classification and documentation
• Evaluate product impact of deviations, aligning with batch release requirements and quality standards
• Author, own, and drive investigations through to timely and compliant closure; update SOPs as relevant to Deviations/CAPAs
• Apply structured root cause analysis methods to identify causes of process and product deviations
• Ensure investigations are complete, accurate, and fully supported with robust documentation
• Design and execute experiments or studies 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 through Good Manufacturing Practice systems and training
• Deliver training and communication to reinforce quality practices and maintain compliance

Essential Requirements

• 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
• Strong understanding of current good manufacturing practices and regulatory expectations for biologics manufacturing
• Excellent technical writing skills, with the ability to clearly structure investigations and present findings

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.

Accessibility and accommodation

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e‑mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Business Processes, Data Analytics, digital skills (Inactive), General Hse Knowledge (Inactive), Good Manufacturing Practices (GMP), Resilience