Associate - Quality Assurance

Eli Lilly and; Sesto Fiorentino; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

A global healthcare leader in Sesto Fiorentino seeks a QA Associate for the Manufacturing Operations team. The role involves quality oversight, compliance with cGMP standards, and managing quality issues. The ideal candidate holds a Master’s in a scientific discipline and has experience in pharmaceutical operations. Competitive salary and benefits package included.

Servizi

Competitive Salary

Relocation Package

Comprehensive Benefits

Competenze

• Experience in pharmaceutical industry operations will be a strong plus.
• Good knowledge of English.
• Ability to prioritize and assess criticality of Quality issues.

Mansioni

• Manage the escalation process in case of Quality issues.
• Collaborate in investigations related to the PFS area.
• Approve Change Controls as part of Quality oversight.

Conoscenze

Quality principles

Problem-solving skills

Effective communication

Interpersonal skills

Formazione

Master’s degree in a scientific discipline

Descrizione del lavoro

Overview

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 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 a QA Associate to join our Manufacturing Operations team at the Sesto Fiorentino (FI) site, within the Pre-Filled Syringes (PFS) area.

In this role, the QA Associate reports directly to the Quality Manager and acts as the Quality point of contact for the PFS area. The role ensures the application of cGMP and Eli Lilly Quality standards, supporting compliance and driving a strong Quality culture. Depending on seniority, the scope of responsibilities and complexity of activities may evolve.

Responsibilities

• Manage the escalation process in case of Quality issues within the production area
• Support inspection readiness for Regulatory Agencies and contribute to the site self-inspection program
• Collaborate in investigations related to the PFS area, performing Quality Assessment of observations and deviations in Trackwise
• Approve Change Controls (CHG) as part of Quality oversight
• Perform Batch Review and Batch Disposition of semi-finished products
• Review procedures (QP/LV) and serve as instructor for selected trainings and procedures
• Execute Quality process monitoring and provide inputs for documentation such as APR and AQMS
• Act as Media Fill observer
• Approve work orders, where applicable
• Contribute to site Quality Systems and Quality Culture initiatives

Requirements

• Master’s degree in a scientific discipline
• Experience in pharmaceutical industry operations will be a strong plus
• Good knowledge of English
• Strong grasp of Quality principles and their application in pharmaceutical manufacturing
• Ability to prioritize and assess criticality of Quality issues, with strong problem-solving and decision-making skills
• Effective communicator with solid interpersonal, influencing, and teamwork abilities
• Organized, pragmatic, and compliance-oriented mindset

What We Offer

Step into a role where your expertise is recognized, appreciated, and rewarded. As a member of our team, you can expect:

• Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives.
• Relocation Package: You will be eligible for a relocation package based on your location.
• Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

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