ppWith more than 30 different sterile products supplied to over 120 countries, our site operates in a highly regulated and globally impactful environment. As a postgraduate in the QA Compliance department, you will provide expert support in inspection management, compliance activities, and the implementation of the Novartis Quality Management System. In this role, you will help ensure that all site- and product-related activities comply with cGxP requirements, including data integrity principles, Novartis internal quality standards, and applicable international and local regulatory requirements. /ph3Your responsibilities include but are not limited to: /h3ulliSupports the preparation and coordination of Annual Product Quality Review activities in accordance with Novartis procedures. /liliSupports third‑party management activities and related compliance processes. /liliContributes to the implementation and continuous improvement of Quality Systems. /liliParticipates in on‑site health authority inspections and customer audits. /liliSupports continuous improvement initiatives within the QA Compliance department. /liliSupports CAPA tracking as well as the preparation, reporting, and review of QA department metrics, including Monthly Quality Reports and KPI reports. /liliCollaborates with cross‑functional teams across Manufacturing and Quality Management. /liliEnsures that all assigned activities and projects are performed in compliance with cGxP requirements, including data integrity principles. /li /ulh3Minimum Requirementsh3Whatyou’ll bring to the role: /h3ulliUniversity degree or postgraduate qualification in Chemistry, Pharmacy, Microbiology, Biotechnology, or a related scientific discipline. /liliBasic knowledge of current GMP requirements and relevant regulatory guidelines, such as ICH, FDA, and EMA expectations. /liliInitial experience in a pharmaceutical manufacturing environment and/or in QA/QC is beneficial. /liliStrong communication skills, with the ability to collaborate effectively across functions. /liliGood organizational skills, including effective time and self‑management. /liliBasic understanding of GMP auditing processes is an advantage. /liliProficiency in English and German, both written and spoken. /li /ulh3Commitment to Diversity Inclusion: /h3 /h3pNovartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. /p /p #J-18808-Ljbffr
QA Compliance Postgraduate - German Speaker Arbeitgeber: Novartis
Novartis in Schaftenau, Österreich, ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Möglichkeit, an globalen Projekten zu arbeiten und einen bedeutenden Einfluss auf die Gesundheitsversorgung zu haben, macht Novartis zu einem attraktiven Arbeitsplatz für Fachkräfte im Bereich Regulatory Affairs.
