Job Description Summary
Internal title: AS&T Expert
Job Description
Key Responsibilities
Lead analytical method validation, verification and transfer activities supporting routine Quality Control laboratory testing.
Write, review and execute protocols and reports following International Council for Harmonisation guidelines, pharmacopoeias and standard operating procedures.
Serve as the analytical expert for assigned Quality Control methods and technical transfer activities.
Maintain and improve analytical methods for release, stability and in‑process testing performance.
Contribute analytical expertise to regulatory submissions, variations and health authority responses.
Act as a Quality control analytical expert during audits and inspections, ensuring clear explanations and inspection‑ready documentation.
Implement updates driven by pharmacopoeias and regulatory expectations within Quality Control laboratories.
Perform regular reviews of analytical methods and computerized laboratory systems using testing data and product knowledge.
Support planning, execution and tracking of the analytical Validation Master Plan.
Drive introduction of new technologies and improvement projects within Analytical Science and Quality Control laboratories.
Essential Requirements
Several years of experience in Quality Control, Analytical Science and Technology, or analytical development within pharmaceuticals or biotechnology.
Hands‑on experience with routine Quality Control testing in a Good Manufacturing Practice environment.
Strong practical knowledge of core laboratory techniques such as elemental analysis and radiation measurement, depending on product needs.
Experience with analytical method validation, verification and transfer, following international guidelines and pharmacopoeias.
Ability to analyze and interpret analytical data using chromatography systems and laboratory data trending tools.
Good understanding of Good Manufacturing Practice, data integrity principles and Quality Control laboratory workflows.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Health & Safety Regulations Knowledge, Leadership, Operational Excellence, Organizational Saviness, Problem Solving Skills, Regulatory Requirements knowledge, Smart Risk Taking