QA Operations Expert

Novartis; Österreich; Vor Ort; EUR 59.000 - 72.000; Vollzeit

Benefits dieser Stelle

Market-competitive base salary

Company pension scheme

Childcare facilities

Learning and development opportunities

Zusammenfassung

Novartis in Austria is seeking a Quality Assurance professional to support introduction of new autoinjector devices to the commercial phase and manage primary packaging and device suppliers from a quality perspective.

You will ensure operations comply with cGMP, QA agreements, regulatory requirements and the Novartis Quality Manual, following SOPs. Fluent English is required; German is desirable.

Qualifikationen

• For this role, a university degree in a relevant field is required.
• Minimum 3 years of experience in MS&T, QC, QA or medical device industry.
• Experience with third party management and external suppliers is preferred.
• Fluent English, written and spoken; German is a plus.

Aufgaben

• Manage third party device component and primary packaging suppliers.
• Evaluate and implement changes related to materials.
• Oversee incoming testing for cGxP compliance and data integrity.
• Review production, QC, and AS&T records.
• Support exception investigations and DHF/DMR approvals.
• Report technical complaints/adverse events within 24 hours.
• Support OpEx improvement projects.

Kenntnisse

MS&T

QC

QA

Medical device industry

Third party management

Data integrity

Ausbildung

University degree in Engineering/Pharmacy/Biochemistry/Biotechnology/Chemistry/Microbiology

Jobbeschreibung

Summary

Location: Schaftenau.

As part of our team, you will be supporting introduction of new autoinjector devices to commercial phase and manage the primary packaging and/or device suppliers from a quality point of view.

You will be responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreements, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.

About The Role

Major accountabilities

• Responsible for third party management of device component and primary packaging material suppliers.
• Responsible for evaluation and implementation of changes related to assigned materials.
• Oversight of incoming testing activities, ensuring compliance with cGxP, incl. data integrity and eCompliance.
• Review and approve of production, QC, and AS&T records.
• Support exception investigations.
• Review and approval of DHF and DMR documents for Commercial medical devices and combination products.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Support OpEx improvement projects.

Essential Requirements

• University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent.
• At least 3 years or more experience in MS&T, QC, QA or medical device industry.
• Experience in relevant operations or third party management.
• Fluent knowledge of English language (written and spoken).
• Flexibility to work in a fast paced, quickly changing work environment.

Desirable Requirements

• Experience in negotiations and global collaboration.
• Fluent in German.

Rewards

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 € 65,605.54/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

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.

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 (PDF 30 MB)