QA Compliance Postgraduate - German Speaker

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. /p h3Responsibilities /h3 ul liSupports the preparation and coordination of Annual Product Quality Review activities in accordance with Novartis procedures. /li liSupports third‑party management activities and related compliance processes. /li liContributes to the implementation and continuous improvement of Quality Systems. /li liParticipates in on‑site health authority inspections and customer audits. /liliSupports continuous improvement initiatives within the QA Compliance department. /li liSupports CAPA tracking as well as the preparation, reporting, and review of QA department metrics, including Monthly Quality Reports and KPI reports. /li liCollaborates with cross‑functional teams across Manufacturing and Quality Management. /li liEnsures that all assigned activities and projects are performed in compliance with cGxP requirements, including data integrity principles. /li /ul h3Minimum Requirements /h3 h3What you’ll bring to the role /h3 ul liUniversity degree or postgraduate qualification in Chemistry, Pharmacy, Microbiology, Biotechnology, or a related scientific discipline. /li liBasic knowledge of current GMP requirements and relevant regulatory guidelines, such as ICH, FDA, and EMA expectations. /li liInitial experience in a pharmaceutical manufacturing environment and/or in QA/QC is beneficial. /li liStrong communication skills, with the ability to collaborate effectively across functions. /li liGood organizational skills, including effective time and self‑management. /li liBasic understanding of GMP auditing processes is an advantage. /li liProficiency in English and German, both written and spoken. /li /ul h3Commitment to Diversity Inclusion /h3 pNovartis 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