Collaborate cross-functionally to assess deviation impact and maintain compliant operations
Develop, document, and implement effective corrective and preventive actions
Monitor CAPA effectiveness and ensure execution through Good Manufacturing Practice systems and training
Deliver training and communication to reinforce quality practices and maintain compliance
Essential Requirements
Bachelor’s degree in a relevant field with pharmaceutical industry experience
Fluency in written and spoken English
Two to five years of experience in a pharmaceutical, facilities, engineering, or quality environment
Hands-on experience with deviation management and writing investigations in a GMP environment
Proven experience in CAPA management, including creation, implementation, and effectiveness tracking
Strong root cause analysis skills using structured investigation methodologies
Strong understanding of current good manufacturing practices and regulatory expectations for biologics manufacturing
Excellent technical writing skills, with the ability to clearly structure investigations and present findings
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to tas.mexico@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Business Processes, Data Analytics, digital skills (Inactive), General Hse Knowledge (Inactive), Good Manufacturing Practices (GMP), Resilience
