Micro QC & AS&T Expert

Novartis ACC; Saluggia; In loco; EUR 45.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Saluggia, Italy, is seeking a Micro QC & AS&T Expert. This role involves managing and validating analytical methods, ensuring compliance with GMP standards, and leading laboratory improvements. Candidates should hold a degree in Biology, Microbiology, or Biotechnology and have previous experience in a GMP environment. Fluency in Italian and English is required. Join us to contribute to innovative science that changes patients’ lives.

Competenze

• Experience in a GMP environment is required.
• Previous experience in handling deviations and investigations.

Mansioni

• Manage and validate analytical methods.
• Lead qualification of new equipment and ensure compliance.
• Collaborate in auditing and compliance improvement.

Conoscenze

Analytical methods development

GMP compliance

Problem identification

Fluent in Italian

Fluent in English

Formazione

Degree in Biology/Microbiology/Biotechnology

Descrizione del lavoro

Summary

The Micro QC & AS&T Expert manages and guarantees the fulfillment of AS&T's own tasks in the Laboratory.

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

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