Summary
-This position is responsible for the manages Quality aspects&projects within area of responsibility. He/she supports analytical investigations, validation, remediation, transfer and implementation of analytical methods. He/she works cross-functionally with MSandT(Manufacturing Sciences and Technology), Development and the Novartis networks to ensure the success of assigned projects.
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
Want more jobs like this?
Get Software Engineering jobs in Sultanbeyli, Turkey delivered to your inbox every week.
• 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
Division
Operations
Business Unit
Innovative Medicines
Location
Turkey
Site
İstanbul Kurtköy
Company / Legal Entity
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No