Senior QC Specialist ( 1 Year Novartis Contract)

Major accountabilities:

• Coordinate, review and release of quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements
• Maintain excellent planning and collaboration with project team members (e.g. laboratory analysts, production specialists, manufacturing science and technology, quality assurance, regulatory CMC, project leaders and colleagues)
• Participate in or create, review, approve registration documents
• Manage analytical weak points of assigned pipeline
• Perform deviations/OOX investigation
• Support troubleshooting for testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis, Bioburden and Endotoxin
• Lead validation and transfer activities for analytical procedures
• Lead qualification, maintenance, and calibration of instruments
• Lead LabOpex Projects

Key performance indicators:

• Timely completion of key deliverables
• Prompt reporting of missed deadlines and aim for shortest possible lead times
• Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities continuous readiness for inspection
• Proactively identify and implement cost-reducing optimizations

Minimum Requirements:

• MSc or PhD in biotechnology, analytical chemistry or related field, +3 years industry experience
• Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage
• Reliability, flexibility, resilience, and strong teamwork skills

Skills:

• Continuous learning
• Dealing with ambiguity
• Decision making
• GMP
• Industry standards
• Laboratory equipment
• Laboratory excellence
• Quality Control (QC) testing
• Quality Control sampling
• Self awareness
• Technological expertise

Languages :

• Fluent in English and German (spoken and written)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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