*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 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).
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*: