Facilities Deviation Writer

Job description

#LI-HybridLocation: Mexico City, MexicoRelocation 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.

Responsibilities

Key ResponsibilitiesOpen and assess deviations within required timelines, ensuring accurate classification and documentationEvaluate product impact of deviations, aligning with batch release requirements and quality standardsAuthor, own, and drive investigations through to timely and compliant closure; update SOPs as relevant to Deviations/CAPAsApply structured root cause analysis methods to identify causes of process and product deviationsEnsure investigations are complete, accurate, and fully supported with robust documentationDesign and execute experiments or studies to support investigation outcomesCollaborate cross-functionally to assess deviation impact and maintain compliant operationsDevelop, document, and implement effective corrective and preventive actionsMonitor CAPA effectiveness and ensure execution through

Good Manufacturing Practice systems and trainingDeliver training and communication to reinforce quality practices and maintain complianceEssential RequirementsBachelor’s degree in a relevant field with pharmaceutical industry experienceFluency in written and spoken EnglishTwo to five years of experience in a pharmaceutical, facilities, engineering, or quality environmentHands-on experience with deviation management and writing investigations in a GMP environmentProven experience in CAPA management, including creation, implementation, and effectiveness trackingStrong root cause analysis skills using structured investigation methodologiesStrong understanding of current good manufacturing practices and regulatory expectations for biologics manufacturingExcellent technical writing skills, with the ability to clearly structure investigations and present findingsCommitment to

Diversity and InclusionNovartis 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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.