Sammanfattning
About the Role
Major accountabilities:
•Manage Quality AS&T Hub aspects & projects within area of responsibility
•Ensure and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems
•Oversight of all Analytical Science & Technology Hub activities including method development, method validation and method transfer, ensures compliance with cGxP, incl. data integrity & eCompliance
•Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements
•Resource and capacity (people and equipment) planning and workload management
•Coordination and leadership of departmental operational activities
•Line responsibility & daily walkthrough
•Lead OpEx Projects
•Investigation of Deviation, OOx, Complaints
•Define and implement CAPAs
•Track team metrics and ensure KQI/KPI meet requirements
•SOP review & revision
Minimum Requirements:
University degree in Pharmacy, Chemical Engineering or Chemistry
•Minimum 5 years of Analytical Laboratory experience with equipments e.g. HPLC, GC, UV/Vis and Wet Chemistry preferably at a pharmaceutical company
•Proven experience in team leadership and performance management
•Knowledge of cGMP& cGLP and basic SAP
•Ability to work in a fast-paced changing environment
•Team working and customer oriented mindset
•Good analytical thinking skills
•Strong interpersonal written and verbal communication skills
•Good knowledge of MS Office applications
•Good command of English is required
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
