Deviation Investigator - GMP Quality (Hybrid, Mexico City)

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.; Ciudad de México; Hybrid; MXN 520,000 - 760,000; Full time

Job summary

Novartis in Mexico City is seeking a Deviations Investigator to join the quality, facilities, and engineering team within a GMP environment. You will open and assess deviations, classify and document them, and support batch release while meeting quality standards.

You will lead investigations to closure, develop CAPAs, update SOPs, and ensure robust documentation. You’ll collaborate across functions and deliver training to reinforce quality practices and regulatory alignment.

Qualifications

• Bachelor’s degree in a relevant field with pharmaceutical industry experience.
• Fluency in written and spoken English.
• 2–5 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.

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.

Skills

Fluency in English

GMP knowledge

Root cause analysis

Investigations writing

CAPA management

Technical writing

Education

Bachelor’s degree in a relevant field

Job description

Novartis in Mexico City is seeking a Deviations Investigator to join the quality, facilities, and engineering team within a GMP environment. You will open and assess deviations, classify and document them, and support batch release while meeting quality standards.

You will lead investigations to closure, develop CAPAs, update SOPs, and ensure robust documentation. You’ll collaborate across functions and deliver training to reinforce quality practices and regulatory alignment.