QC Specialist II

About Novartis Pharmaceutical Manufacturing GmbH

We are a leading pharmaceutical company dedicated to improving and extending people's lives. Our mission is to become the most valued and trusted medicines company in the world.

Job Summary

We are seeking a highly skilled and experienced laboratory professional to contribute to our analytical reviews, scientific and investigational support, research support, and stability testing.

Key Responsibilities

• Handling of Out-of-Specification (OOS) cases and deviations
• Implementing changes and supporting transfers
• CAPA definition and preventative actions
• Contribution to Key Performance Indicators (KPIs) and operational excellence
• Ensuring all activities are in compliance with current Good Manufacturing Practices (cGMP), including data integrity review and approval of analytical data/tests (analytical release), stability testing
• Preparation of Standard Operating Procedures (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 maintaining equipment, including 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

Requirements

• Completed studies in Process Engineering, Biotechnology, Biology, Pharmaceutical Technology, Technical Chemistry, or comparable studies, with a minimum of a Bachelor's degree and 5 years of work experience or a Master's degree with 2 years of work experience
• Experience in the pharmaceutical industry, preferably analytical laboratory testing of large molecules or development, with good GxP knowledge
• Proficiency in English and German (spoken and written)

What We Offer

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, and 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/year (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 to part-time and job-sharing models and support flexible and remote working where possible.