Sesto Fiorentino, Italy
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 39,000 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.
Eli Lilly Italia is looking for two profiles of Quality Assurance Associate, respectively:
- PFS QA Visual Inspection Associate
- Insulin QA Filling Associate
The resources will report to Sr Managers of the area and will be responsible for ensuring the application of cGMP and Lilly standards. Moreover, they will be part of the Process Team and will be responsible for managing Quality issues as the Quality contact within the Process team. Responsibilities of the role may vary depending on seniority and increasing complexity of the process.
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 Process 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;
Master’s Degree (Scientific)
Good knowledge of English (at least B2 CEFR)
Experience in pharmaceutical industry operations is preferred;
Knowledge of current GMP's, pharmaceutical legislation and regulatory requirements;
Understanding of Quality principles and their applications in pharmaceutical manufacturing;
Knowledge of sterile and packaging manufacturing processes;
Prioritization skills and ability to determine the criticality of Quality issues;
Problem solving skills and decision making attitude;
Communication and influencing skills;
Good team working/partnership skills to working within a cross-functional organization;
Pragmatic approach and compliance mindset
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-4804.
Lilly is an EEO/Affirmative Action Employer and 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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