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**:
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** 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.

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

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.