QA Operations Expert (m/w/d), Schaftenau, Tirol

Summary

#LI-Hybrid
As a QA Operations Expert, you will ensure that our operations meet the highest quality standards. You'll manage quality processes within your area, ensuring full compliance with cGMP, regulatory requirements, and the Novartis Quality Manual. Your work will help guarantee that all activities are executed according to Quality Assurance Agreements and Standard Operating Procedures.

Join our team and help us drive quality excellence across every step of our operations!

About the Role

Key Responsibilities:

• Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
• On-time and GMP-compliant release of dosage forms
• Support exception investigations
• Review and approval of production, QC, and AS and T records and MBR review
• Support OpEx improvement projects Qualified Person
• Executes batch release in compliance with registration
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)
• Successfully Support continuous improvement Projects

Essential Requirements:

• University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
• Professional experience in Pharmaceutical industry, Biopharmaceutical or API products and at least 2 years within QA, thorough knowledge of cGMP requirements
• Accountability: takes responsibility for his/her tasks and is reliable
• Decision Making: correctly interprets analyses and evaluations and correctly identifies which measures should be taken
• Ability to work in a team: has the ability to contribute constructively and reliably in a group as well as results driven when motivating himself/herself and others to obtain good results and ensures observance of ethical and legal principles
• Customer focus: gives customer satisfaction highest priority and continuously striving for improvementand quality focus when providing the highest quality products and services, which meet the needs and requirements of internal and external customers
• English required, German highly recommended

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 €64.023,54/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.

Commitment to Diversity and Inclusion:

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

Accessibility and accommodation:

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.

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

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