摘要
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).
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Ajustes de accesibilidad
Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para des empeñar las funciones esenciales de un puesto, envíe un correo electrónico a [email protected] y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.
