<< ZURÜCK
BEWERBEN
von: Innovative Medicines
Summary
We are seeking a motivated QC-Analyst for Biopharmaceutical Production within the framework of raw materials, drug substance, and in-process controls. The candidate will perform analytical testing and ensure compliance with SOPs, analytical methods, and compendial standards.
About the Role
Major accountabilities:
· Conduct and coordinate quality control tests on biologics drug substances (Physicochemical testing, e.g. HPLC, Capillary Electrophoresis, UV) ensuring compliance with regulatory requirements
· Independent planning, implementation, and evaluation of routine and special analyses in a GMP-regulated environment
· Interpret test data, prepare detailed reports, and maintain accurate record of test results.
· Troubleshoot testing procedures and make recommendations for improvements, with a focus on HPLC and Capillary Electrophoresis
· Conducting microbiological tests such as total germ count determinations (MET) and bacterial endotoxins (BET)
· Participate in the validation of analytical procedures
· Collaborate closely with the internal teams to optimize quality control processes
· Instrument responsibilities, including qualification, maintenance, and calibration documentation
· Support in ensuring that the laboratory is maintained in a ready state of inspection.
Key performance indicators:
· Timely test record completion and accurate processing without delays
· Prompt reporting of missed deadlines and aim for shortest possible lead times
· Continuous readiness for inspection
· Consistently follow the GMP and GSU guidelines, and SOPs, ensuring no critical irregularities
· Proactively identify and implement cost-reducing optimizations
· Complete all assigned training as per the provided plan
Minimum Requirements:
· Completed scientific education (e.g., Laboratory Technician, Bachelor or Master)
· Practical experience in a GMP-regulated lab and document creation
· Knowledge in common analysis techniques, especially HPLC and photometry; microbiological knowledge is an advantage
· Working experience in laboratory environment in the pharmaceutical industry
· Good IT skills (MS Office) and laboratory software like LIMS, Chromeleon, Empower are an advantage
· Ability to work precisely, independently, and proactively
· Reliability, flexibility, resilience, and strong teamwork skills
· Shift work with normal working times (one shift) including weekends
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 German (spoken and written) and proficient in English
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?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
<< ZURÜCK
BEWERBEN