QA Specialist Operations

Descripción del puesto:

Job Description SummaryQA Specialist Operations manages quality aspects and projects within area of responsibility, ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

This is a 50% part-time job.

Job Description
Major accountabilities:
* Perform batch record review (BRR) and ensure timely, GMP-compliant batch release in alignment with regulatory requirements
* Oversee completeness and accuracy of production and QC documentation, including preparation of release packages
* Support exception investigations and resolve documentation gaps in collaboration with cross-functional teams
* Drive continuous improvement initiatives (OpEx), including process optimization and digitalization (e.g., transition to electronic batch records)
* Analyze recurring documentation issues and implement standardization measures to prevent errors
* Prepare for audits and inspections, ensuring compliance with cGxP and data integrity standards
* Actively participate in QA meetings to monitor progress, identify bottlenecks, and ensure on-time release
* Oversight of all production and testing activities ensures compliance with cGxP.

​Minimum Requirements:
* Experience in Quality Assurance, Manufacturing, or a GMP-regulated environment, preferably within the pharmaceutical industry
* Experience with release processes, batch record review
* Familiarity with GMP regulations, audit preparation, and quality documentation
* Hands-on experience working with cross-functional teams (e.g., Manufacturing, QC, Engineering)
* Preferred: Experience with SAP, 1QEM, or other QA-relevant systems
* fluent German is required, English language desired

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 EUR 59.781,96 /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

Skills DesiredContinued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence