Associate - FUME & CSQA

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 - Engineering & Computer System to join our Manufacturing Team in Sesto Fiorentino. He/She will be responsible of ensuring that Validation/Qualification is compliant with LQS, LQP and Local SOP and that computer systems are validated and remain so throughout the life cycle of the system. In addition to this, he/she will support cross-functional teams in investigating and addressing CSQA (Computer Software Quality Assurance) and FUME (Facility, Utilities, Maintenance, Equipment) non conformances. He/she will also conduct problem solving and root cause analysis to address maintenance and computer system failures identified. Main responsibilities of the role: Ensure alignment with GMP standards, granting Q oversight over the Computer Systems and FUME area Approve the maintenance program, the Preventive maintenance Plan and work instruction (if applicable) Approve CSV deliverables, CQWP, IQ/OQ deliverables Guarantee oversight of the activities related to team members of Engineering and MI&CS delivery & Support, MI&CS Process Automation Cooperate in the investigation of deviation computer system and maintenance related Implement corrective action plans to avoid recurrency of deviations maintenance and CS related Approve change control activities maintenance and computer system related Approve deviations maintenance and computer system related Review and approve maintenance and computer system related SOPs Guarantee the compliance of the activities of the department with respect to the quality related gap analysis Cooperate to the definition of maintenance and IT activities related to shut-down and return to service Create, maintain and publish FUME and IT-Q trends Minimum requirements: Scientific Master’s Degree (Engineering/Chemistry preferred) Good knowledge of English (B2/C1 level) Knowledge of manufacturing computer system Knowledge of production processes and quality environment Previous experience in manufacturing activities Additional Skills/Preferences: CSQA certification Attitude to team working Organizational and relational skills 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. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly