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Facilities Deviation Writer
Real Estate Property
💰 Salary Not shared
📊 Market NA
About the Company
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
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
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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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