QA Senior Specialist

Summary

We are seeking a Quality Assurance professional to ensure GxP compliance, product quality, and adherence to Novartis Manufacturing Manual and regulatory standards. Responsibilities include managing quality systems, deviations, CAPAs, audits, training, and environmental monitoring. The role also supports product release, validation, and transfer projects while ensuring qualified facilities, business continuity, and compliance with HSE, DI, and eCompliance requirements. This is a 50% part-time position.

About the Role

Major accountabilities:

• Ensure compliance with Novartis Manufacturing Manual, GxP standards, and regulatory requirements.
• Oversee site quality systems, product quality, and local health authority registrations.
• Maintain qualified facilities and utilities; manage deviations, complaints, CAPAs, and environmental monitoring.
• Support PQR/APQR preparation, product release, validation, and transfer projects.
• Review and approve MBRs, specifications, SOPs, and other GxP documents.
• Drive training execution, data integrity, eCompliance, and adherence to HSE guidelines.
• Collaborate in audits and manage quality agreements with third parties.
• Ensure business continuity and compliance with all corporate and local legal requirements.

Essential Requirements:

• Microbiology or finalized apprenticeship in an area of the Pharmaceutical industry (e.g. chemical laboratory worker, chemical worker or related fields / internal specific education (\’Modulausbildung\‘) or equivalent
• Fluent in German and intermediate proficiency in English

You´ll receive:

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 € 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.

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 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.

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?

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:

Benefits and Rewards: Read our handbook to learn about all the ways we\’ll help you thrive personally and professionally:

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?

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:

Benefits and Rewards: Read our handbook to learn about all the ways we\’ll help you thrive personally and professionally:

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

Regular

Shift Work

No

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 (email protected) 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.

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