Summary
-The role is responsible for coordination and management of analytical equipment related activities as well as to provide scientific analytical Support. This includes the evaluation, development and validation of methods required for raw materials and finished products. -Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project. -Organizes and interprets all data obtained using a wide variety of instrumental technologies
About the Role
Major accountabilities:
• Ensure that Novartis and Health Authority requirements concerning the AS&T Department are fully met.
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• Execute the main activities according to prepared SOPs and laboratory rules.
• Fulfill the responsibilities, which are given by AS&T Coordinator and AS&T Manager, at the right time and correctly in conformance with methods, procedures and work flow.
• Following the global analytical method development studies, current guidelines and pharmacopeia.
• Routinely assess testing monographs and proactively sustain compliance of all activities with current official regulations, pharmacopeias, QM, QD, GOP and SOP.
• Evaluate and implement new technologies required to maintain state-of-the- art analytical methods for development and marketed products.
• Execute analytical method development, pre-validation and validation studies.
• Ensure right first time in all analysis and documentation.
• Prepare the related CTD documents of updated testing monograph.
Minimum Requirements:
• University degree in Pharmacy, Chemical Engineering or Chemistry
• Minimum 3 years of Analytical Laboratory experience with equipments e.g. HPLC, GC, UV/Vis and Wet Chemistry preferably at a pharmaceutical company
• 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
Work Experience:
• Sound technical & scientific knowledge of pharmaceutical/ chemical.
• analytics/QC/R&D/ equivalent.
Skills:
• Communication Skills.
• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gxp.
• Industry Standards.
• Laboratory Equipment.
• Laboratory Excellence.
• Self Awareness.
• Technological Expertise.
• Total Quality Management.
Languages :
• English.
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
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Division
Operations
Business Unit
Innovative Medicines
Location
Türkiye
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