AS&T Specialist

REQ-10009009

May 28, 2024

Turkey

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.•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.

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Operations

Pharmaceuticals

Turkey

İstanbul Kurtköy

TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.

Quality

Full time

Regular

No

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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

REQ-10009009

AS&T Specialist

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Quality Operations Turkey

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