• Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints; person of contact for analytical questions from health authorities and analytical subject matter expert during audits and inspections

• 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:

• University degree or FH with natural science/technical background (e.g. chemistry, pharmacy, biology) 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

• External orientation: proactive communication, collaboration and exchange with PUs and SUs within local organization and Novartis organization.

• Continuously thrives for improvements and questions processes and procedures for improvements

• Reacts in a flexible and fast way on changes and challenges; ability to analyze complex processes.

• Supports as analytical expert the PUs and SUs and other colleagues for complex tasks

• Fluent in English and German

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 € 60.600/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
Full time

Employment Type
Regulär

Shift Work
No