AS&T Expert

Job ID

REQ-10051279

May 13, 2025

Austria

Summary

Part time job: 50% or 70% employment

Responsible for managing all analytical aspects within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual - all conducted according to the relevant Standard Operating Procedures. Ensure analytical Life Cycle Management for commercial products and ensure analytical implementation for new projects in-time.

About the Role

Major Accountabilities:

• 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
• Overview and Management of Final Dosage Form testing for release and stability; functional testing of medical devices
• Scientific analytical support for quality control, production, registration; 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

Essential Requirements:
• Approx. 5 to 8 years in pharmaceutical industry and/or analytical laboratory in GMP environment (ideally with medical devices)

• Knowledge of GMP, Quality Control (QC) Testing and Quality Standards experience

• Project Management and Analytical Expertise

• Proactive communication, collaboration and exchange with PUs and SUs within local and Novartis organization

• Continuously thrives for improvements and questions processes and procedures for improvements
• Fluent English is required, German desired

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

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 65.605,54/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

We are open for part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & Inclusion:

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

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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

Division

Operations

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Quality

Job Type

Part time

Employment Type

Regulär

Shift Work

No

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Unterstützungen für BewerberInnen mit Behinderungen

Wenn Sie aufgrund einer Erkrankung, einer körperlichen Behinderung oder eines neurodiversen Zustandes eine Unterstützung bei terschiedlichen Teilen des Rekrutierungsprozesses benötigen, wenden Sie sich bitte an disabilities.austria@novartis.com und teile n Sie uns die Art Ihrer Anfrage sowie Ihre Kontaktinformationen mit. Unsere Unterstützung umfasst die Beratung zu geeigneten Positionen sowie die Begleitung bei allen Phasen des Bewerbungsprozesses. Das österreichische Gesetz sieht die Möglichkeit vor, die örtliche Behindertenvertrauensperson (BVP) in das Bewerbungsverfahren einzubeziehen. Wenn Sie dies wünschen, teilen Sie uns dies bitte vorab als Vermerk in Ihrem Lebenslauf mit.

Job ID

REQ-10051279

AS&T Expert

Apply to Job

Quality Operations Austria

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