**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, 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**
**Benefits and Rewards**: Learn about all the ways we'll help you thrive personally and professionally.
- Read our handbook (PDF 30 MB)
Division
Operations
Business Unit
Production / Manufacturing
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Accessibility and accommodation**:

📌 Facilities Deviation Writer (Xico)
🏢 Novartis
📍 Xico