Job Description Summary
The Micro QC & AS&T Expert manages and guarantees the fulfillment of AS&T's own tasks in the Laboratory.
Job Description
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.
Skills Desired
Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management