Quality Assurance Associate

1 giorno fa

Sesto Fiorentino, Italia Eli Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**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 Process 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)
- Knowledge of current GMP's, pharmaceutical legislation and regulatory requirements;
- Problem solving skills and decision making attitude;
- Good team working/partnership skills to working within a cross-functional organization;

**Additional Skills/Preferences**:

- Experience in pharmaceutical industry operations is preferred;
- Knowledge of sterile and packaging manufacturing processes;
- Prioritization skills and ability to determine the criticality of Quality issues;
- Pragmatic approach and compliance mindset;

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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