Key Responsibilities
-
Open and assess deviations within required timelines, ensuring accurate classification and documentation
-
Evaluate product impact of deviations, aligning with batch release requirements and quality standards
-
Author, own, and drive investigations through to timely and compliant closure; update SOPs as relevant to Deviations/CAPAs
-
Apply structured root cause analysis methods to identify causes of process and product deviations
-
Ensure investigations are complete, accurate, and fully supported with robust documentation
-
Design and execute experiments or studies to support investigation outcomes
-
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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
