Band
Level 3
Job Description Summary
#LI-Hybrid
Job Description
Key Responsibilities
Open and assess deviations, determining criticality within defined timelines
Evaluate product impact of deviations in alignment with batch release activities
Author and own investigations, ensuring clear scope, root cause, and timely closure
Apply structured root cause analysis tools to identify product and process deviations
Develop, document, and implement effective Corrective and Preventive Actions
Verify robustness and effectiveness of critical and major investigations
Execute experiments or manufacturing runs to support investigation outcomes
Collaborate cross-functionally to ensure compliant production during deviations
Generate manufacturing orders within the Manufacturing Execution System as required
Deliver targeted training to reinforce quality practices and compliance standards
Essential Requirements
Bachelor’s degree in a scientific field, with two to five years of pharmaceutical industry experience
Proven experience working in a Good Manufacturing Practice production environment, preferably aseptic or sterile
Demonstrated experience leading deviation investigations and corrective and preventive action activities
Strong knowledge of current Good Manufacturing Practice regulations and regulatory expectations for pharmaceutical manufacturing
Experience applying structured root cause analysis methods to product and process issues
Fluent English and Spanish communication skills, both written and spoken
This role includes participation in a rotating shift model, which involves work on weekends for part of the schedule, with overall working time remaining five days per week and details agreed in advance.
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
Data Analytics, digital skills, General Hse Knowledge , gmp knowledge, process excellence, Resilience