Compliance Specialist
Vor 2 Tagen
Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us QC Specialist II (m/f/d) Schaftenau, Kundl (Tirol) We are looking for a highly skilled and experienced laboratory professional who will contribute to performing analytical reviews, scientific and investigational support, research support and stability testing. Handling of OOx cases and Deviations Implementing changes and supporting transfers CAPA definition and preventative actions Contribution to the KPIs and operational excellence Ensuring all activities are in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release), stability testing. Preparation of SOPs, protocols, laboratory procedures and evaluation reports. Performance of Stability studies, protocols and comparative reports for supplier qualification Providing expert support for site qualification and validation activities Supporting supplier qualifications and maintain equipment incl. plan preparation Supporting sample planning and test execution Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt Continuous Learning. Dealing With Ambiguity. Solution oriented Flexible and resilient working Good analytical thinking and scientific support for the QC operations Experience in coordination, and coordination of internal and external stakeholders. hohe Lernbereitschaft Minimum Requirements:
Completed studies in the field of Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry (or comparable studies), min. Bachelor's degree with 5 years of work experience or Master's degree with 2 years of work experience. Experience in the pharmaceutical industry, preferably analytical laboratory testing of large molecules or development. Good GxP knowledge. Proficiency in English and German (spoken & written). In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €58.199,96/yea r (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job-sharing models and support flexible and remote working where possible. JBTC1_AT
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