QA Deviations Specialist

**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**:hybridCDMX** Major accountabilities**:- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person - Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)** 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 global 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).Accessibility and Accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityMX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.Functional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo**Accessibility and accommodation**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.