摘要
About the Role
Major accountabilities:
• Responsible for the development / validation / verification / transfer / troubleshooting / monitoring of analytical methods.
• Manage the method lifecycle and periodically monitor the performance.
• Lead the qualification of new equipment according to Novartis and regulatory standards.
• Guarantee the compliance with dossiers and relevant pharmacopoeia regarding the testing methods in place and collaborate in the product submission to the Regulatory Authorities for the field of expertise.
• Identify problems, needs and areas for improvement of the laboratory. In accordance with this, design, develop and implement projects that allow improvements in quality, safety and performance of the analysis process in the laboratory.
• Provide technical-analytical-compliance support to the QC- laboratory.
• Ensure that the work in the AS&T field is carried out in accordance with the requirements of the Novartis QMS and in compliance with GMP regulations.
• Guarantee the management of deviations, OOS, OOT, OOE and investigations.
• Collaborate with all the figures in order to detect possible compliance issues.
• Actively contribute to the good success of the audits.
Essential requirements:
• Degree in Biology/Microbiology/Biotechnology.
• Previous experience in a similar role within a GMP environment.
• Experience in handling deviations and investigations.
• Fluent in Italian and 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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
