AS&T Expert

Job description

Job Description Summary The Analytical Science and Technology (AS&T) Expert is responsible for coordinating and managing analytical activities across products, including both customer-related projects and innovative Novartis initiatives, and for providing scientific analytical expertise and support. Job Description: Major Accountabilities: - Coordination and management of analytical method transfers and stability studies - Presentation and discussion of analytical data in local and international project teams. Life-cycle management of analytical methods, including control of method performance, analytical method validation, pharmacopoeia and health authority compliance and definition of method improvements - Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints - Person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections - Cross-functional interface with Manufacturing Science & Technology team, analytical development, production, quality assurance and regulatory department - Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and...