**Summary**:
The Deviations Specialist/ QA Investigator is responsible for managing and executing investigations of deviations and non-conformities within manufacturing and quality control environments.
This role ensures root causes are identified, corrective and preventive actions (CAPAs) are implemented effectively, and documentation complies with cGMP and Novartis standards.
**About the Role**:
**Key Responsibilities**:
- Lead and document investigations related to deviations.
- Perform root cause analysis using tools such as 5 Whys, Fishbone, FMEA, etc.
- Collaborate with cross-functional teams (Production, QC, QA, RA, Supply Chain, Engineering, etc.) and international teams (e.g., Argentina, Chile, U.S.) to gather data, perform root cause analysis and drive timely resolution of investigations.
- Ensure CAPAs are defined, implemented, and verified for effectiveness.
- Maintain investigation records in compliance with internal procedures and regulatory expectations.
- Establish and monitor quality KPIs.
- Provide guidance to Business Partners in the activities related to Deviation process to stablish improvements.
- Act as key user for the deviations system, managing access and troubleshooting.
- Support audits/inspections with documentation and participation in discussions.
- Identify trends and recurring issues to support continuous improvement initiatives.




- Contribute to the development and revision of SOPs related to deviation and CAPA management.
- Foster digitalization and the use of artificial intelligence (AI) within a general framework to optimize and streamline processes.
- Support service implementation and transitions (knowledge transfer, go-live, hyper-care).
**Specific skills and qualifications**:
- Bachelor's degree in pharmacy, Chemistry, Biology, or related scientific discipline.
- Minimum 4 years in pharmaceutical QA (preferably in deviation/CAPA management, GMP, regulatory compliance), local/international Health Regulations and Project management.
- Strong knowledge of cGMP, ICH, and regulatory standards.
- Experience with electronic quality systems (e.g., 1QEM, SAP-QM).
- Excellent analytical, communication, and documentation skills.
- Skilled in cross-functional collaboration and process optimization.
- Familiar with business intelligence, design thinking, agile methodologies, and data management.
- Digital skill
- High responsiveness and customer satisfaction.
- English proficiency and Portuguese (desirable).
Division
Operations
Business Unit
Innovative Medicines
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
**Ajustes de accesibilidad**:

📌 Deviations Specialist (Xico)
🏢 Novartis
📍 Xico