Quality Assurance Operations

1 settimana fa

Sesto Fiorentino FI, Italia Eli Lilly and Company 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 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 seeking a dedicated professional to join our Sesto Fiorentino Site as a Quality Assurance Operations . If you are passionate about quality and innovation and wish to work in a dynamic and collaborative environment, this is the opportunity for you

Main Responsibilities:

As a Quality Assurance Associate, reporting directly to the Associate Director of the relevant area, you will be responsible for ensuring quality, rigorously adhering to cGMP and Lilly standards. You will collaborate with a cross-functional team to manage quality issues and contribute to continuous improvement.

  • Executing Batch Disposition for semi-finished product lots
  • Preparing and supporting during regulatory inspections and self-inspections
  • Investigating and assessing process deviations
  • Approving Level 3 SOPs and training personnel
  • Drafting periodic evaluation documents (APR and AQMS)
  • Observing Media Fill executions
  • Managing quality issue analyses and contributing to sterility assurance problem analyses in your area
  • Assessing and authorizing the implementation of departmental changes
  • Conducting process monitoring for quality aspects
  • Authorizing restarts after area shutdowns
  • Approving extraordinary ODLs

Minimum Requirements:

  • Master's degree in a technical-scientific field (Chemistry, Biology, CTF, Engineering)
  • 2/3 years of experience in pharmaceutical settings, preferably parenteral
  • In-depth knowledge of cGMP
  • Fluent in English
  • Ability to work in cross-functional teams with a strong results-oriented approach
  • Excellent problem-solving and decision-making skills

What we offer:

Step into a role where your expertise is not only recognized and appreciated, but also rewarded. As a member of our team, you can expect:

  • Competitive Salary : We offer a competitive base salary (for this role can be B2 or B1 level CCNL, based on the seniority), supplemented by an annual variable component based on the achievement of objectives.
  • Relocation Package: Based on your location, you will be eligible for a relocation package.
  • Comprehensive Benefits : Enjoy a well-rounded welfare package, including an extensive insurance plan.
  • Annual Salary Review : We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance. As part of our commitment to your future, you may also be eligible to receive a stock option package, aligning your success with the company's growth.

Join us at Eli Lilly Italia and be part of a team dedicated to making a difference in people’s lives

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