QA Operations Lead: Medical Devices & Supplier Quality

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

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.