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Quality Assurance Associate

Eli Lilly Italia is looking for a Quality Assurance Associate to join the Manufacturing Team in Sesto Fiorentino. He/She will report to the Sr Manager of the production department (sterile or packaging
& device lines) and will be responsible for ensuring the application of cGMP and Lilly standards.

Moreover, he/she will be part of the cross-functional team of the area and will be responsible for managing Quality issues as the Quality contact within the team. Responsibilities of the role may vary depending on seniority and increasing complexity of the process.

Main Responsibilities of the role:
Being accountable for the escalation process in case of issues in the production area
Supporting the preparation and ensuring readiness to any Regulatory inspection; supporting site self-inspection program
Participation to investigations related to the area, in cooperation with other functions and the cross-functional team
Performing Quality Assessment of observations and deviations in Trackwise
Having the role of CSQA of the team and approving CHG
Performing Batch Review and Batch Disposition of semi-finished products
Reviewing procedures, QP/LV and acting as instructor of some courses and procedures
Executing the process monitoring for Quality and providing information for writing documents such as APR, AQMS
Being the Media Fill observer
Approving work orders, if applicable
Cooperating in site Quality Systems and Quality Culture initiatives

Minimum Requirements:
Scientific Master’s Degree
Good knowledge of English (at least B2 CEFR)
Understanding of Quality principles and their applications in pharmaceutical manufacturing
Knowledge of current GMP's, pharmaceutical legislation and regulatory requirements
Prioritization skills and ability to determine the criticality of Quality issues
Problem solving skills and decision-making attitude

Additional Skills/Preferences:
Experience in pharmaceutical industry operations is preferred
Knowledge of sterile and packaging manufacturing processes
Communication and influencing skills
Good team working/partnership skills to working within a cross-functional organization
Pragmatic approach and compliance mindset


Degrees of interest: Scientific Master’s Degree