Associate - QA Formulation Line 3

Associate - QA Formulation Line 3

Eli Lilly Benelux

Sesto Fiorentino, Italy

Are you ready to play a key role in ensuring the quality and compliance of cutting-edge pharmaceutical manufacturing operations?

We are looking for a QA Associate to join our Quality team at the Eli Lilly Italia Manufacturing Site in Sesto Fiorentino.

As a QA Associate, you will serve as the primary Quality contact within both the Project Team and the Formulation Cartridges Process Team. You will support the implementation of a new formulation suite from its earliest stages, acting as a trusted partner to cross-functional teams and a key point of escalation for quality matters.

What You'll Do

• Lead quality oversight for the formulation project, including qualification phases and start-up of the new suite
• Ensure consistent application of cGMP standards and Eli Lilly quality requirements across the area
• Serve as the accountable escalation point for quality issues arising in the project or production area
• Support preparation for Regulatory inspections and contribute to the site self-inspection program
• Investigate deviations in the Cartridge area and perform Quality Assessments in Veeva QMS
• Review and approve qualification protocols and procedures
• Act as Media Fill observer and approve work orders where applicable
• Actively contribute to site Quality Systems and Quality Culture initiatives

What We're Looking For

• Master's Degree in a Scientific discipline
• Experience in pharmaceutical industry operations
• Solid knowledge of current GMPs, pharmaceutical legislation, and regulatory requirements
• Good command of English (minimum B2 CEFR level)
• Strong communication and influencing skills
• Collaborative mindset with a pragmatic, compliance-oriented approach