Zusammenfassung
About the Role
AS&T Expert - Quality Operations
Location - Hyderabad
About the Role:
The Analytical Science and Technology (AS&T) Expert is responsible for coordination and management of analytical activities of commercialized products as well 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 well 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/AS&T 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: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
