QA Associate

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 35,000 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 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- Operate as SME for Facility Fit & Finish, Pest Control and Facility cleaning

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

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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