QA Operations Lead - Medical Devices & cGMP

Healthcare Businesswomen’s Association; Österreich; Vor Ort; EUR 59.000 - 72.000; Vollzeit

Zusammenfassung

Novartis is seeking a quality-focused professional to support introduction of autoinjector devices to the commercial phase in Schaftenau, Austria. You will manage device components and primary packaging suppliers from a quality perspective, ensuring cGMP compliance and adherence to QA agreements and regulatory requirements.

Responsibilities include reviewing production, QC and AS&T records, approving DHF/DMR documents, and supporting investigations and OpEx projects.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Collaboration

Communication

Continuous Improvement

Data Integrity

Decision Making

GMP

Leadership

Managing Ambiguity

Operational Excellence

Quality Assurance

Quality Compliance

Quality Control

Quality Inspections

Quality Management Systems

Regulatory Compliance

SPC

Supplier Quality Management

Ausbildung

Bachelor's degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent

Jobbeschreibung

Novartis is seeking a quality-focused professional to support introduction of autoinjector devices to the commercial phase in Schaftenau, Austria. You will manage device components and primary packaging suppliers from a quality perspective, ensuring cGMP compliance and adherence to QA agreements and regulatory requirements.

Responsibilities include reviewing production, QC and AS&T records, approving DHF/DMR documents, and supporting investigations and OpEx projects.