AS&T Expert - Medical Devices (m/w/d)

Summary
Responsible for managing all analytical aspects with focus on Medical Devices and functional testing within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Ensure analytical Life Cycle Management for commercial products and ensure timely analytical implementation for new projects.
About the Role
Key Responsibilities:
• Technical SME for device related analytical methods and functional testing equipment (e.g. ZwickRoell test machines)
• Management and oversight of all analytical activities related within responsible projects (functional testing of devices)
• Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance
• Ensure timely analytical implementation (Method Transfer and Method Validation) for (new) projects during product transfers
• Single point of contact for internal and external clients and contract laboratories
• Scientific analytical support for quality control, production and registration; Subject matter expert in health authority inspections
• Support overarching product investigations (Deviations and OOx) cross functional, e.g. QC, QA, Production, MS&T
• Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, ongoing process verification reports, registration documents)
Essential Requirements:
• University degree or FH with natural science/technical background (e.g. engineering, metrology, chemistry, pharmacy,) or equivalent education
• Approx. 3 to 5 years in pharmaceutical industry and/or analytical laboratory in GMP environment
• MS Office- and other standard IT applications - technical Expertise in ZwickExpert software beneficial
• Fluent in English and German
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
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 and Inclusion / EEO paragraph:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
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