QA Operations Lead - Medical Devices & GMP

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Österreich; Vor Ort; EUR 66.000 - 105.000; Vollzeit

Zusammenfassung

Novartis is seeking a qualified professional at Schaftenau, Austria for MT&S/QC/QA oriented work within medical devices and combination products. The role emphasizes third party supplier management and change implementation, with a focus on data integrity, eCompliance, and regulatory readiness.

The candidate will review records, support investigations, and ensure timely reporting of technical issues, while contributing to efficiency improvements and adherence to GMP/QMS standards in a fast-paced

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

MS&T experience

Quality Assurance

English fluency

Third party management

GXP compliance

Ausbildung

University degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, or Microbiology

Jobbeschreibung

Novartis is seeking a qualified professional at Schaftenau, Austria for MT&S/QC/QA oriented work within medical devices and combination products. The role emphasizes third party supplier management and change implementation, with a focus on data integrity, eCompliance, and regulatory readiness.

The candidate will review records, support investigations, and ensure timely reporting of technical issues, while contributing to efficiency improvements and adherence to GMP/QMS standards in a fast-paced