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AS&T Expert - Quality Operations

AS&T Expert - Quality Operations

NOVARTIS

10 - 15 years

7 - 11 Lacs

Hyderabad

Posted:3 weeks ago| Platform:

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Skills Required

Analytical Stability studies German Manager Quality Control GMP Budgeting quality operations MS Office Continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. About the Role: The Analytical Science and Technology (AST) Expert is responsible for coordination and management of analytical activities of commercialized products as we'll as to provide scientific analytical support. Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports. Compilation of Quality control monographs describing test procedure and specification setup. Scientific analytical support for quality control, production, registration, marketing. Presentation and discussion of analytical data in local and international project teams. Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as we'll as changes and complaints. Cross-functional interface with Manufacturing Science Technology team, analytical development, production and regulatory department. Management and coordination of analytical activities at external laboratories (CROs). Support for trouble shooting activities and continuous improvement initiatives. Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Budgeting and cost control of external analytical activities. Contribution to QC/AST network teams. Management of reference substances and control samples. Essential Requirements: Minimum 10 years in pharmaceutical industry and/or analytical laboratory in GMP environment. MS Office- and other standard IT applications. External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organisation and Novartis organisation. Innovation: continuously thrives for improvements and questions processes and procedures for improvements. Reacts in a flexible and fast way on changes and challenges. Ability to analyse complex processes. Desirable Requirements: Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Language proficiency: English, German optionally. Why Novartis: you'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:

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NOVARTIS

www.novartis.com

Pharmaceutical Manufacturing

Basel Baselstadt

10001 Employees

433 Jobs

Key People

Vas Narasimhan

CEO
Marie-France Tschudin

President, Innovative Medicines
Shivani R. Sharma

Chief Financial Officer
John Tsai

Chief Global Research
David Epstein

Former CEO of Novartis Pharmaceuticals

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AS&T Expert - Quality Operations

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