Summary:
LI-Hybrid
- Location: Mexico City, Mexico
- 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.

About the Role:
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
- 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, implementati

📌 Facilities Deviation Writer (Baja California Sur)
🏢 Novartis
📍 Baja California Sur