Job Title: Quality SpecialistLocation: Guidonia Montecelio, ItalyResponsibilities:Develop and review equipment and process validation projects with a quality focus and risk-based approach.Interact daily with Operations and other key internal/external stakeholders to foster strong relationships.Establish and maintain quality validation methodologies, systems, and practices that meet regulatory requirements.Serve as a representative to improve awareness, visibility, and communication on quality initiatives supporting departmental, site, and divisional goals, including cost reduction projects.Review validation strategies, protocols, and reports with a risk-based approach.Manage project schedules, ensuring strict adherence to critical milestones.Investigate, identify, and implement best-in-class quality practices.Support building quality-related infrastructure and instruments, including preparation of URS, System Risk Assessments, and validation activities.Review the Change Control system to assess the impact of proposed changes on equipment and process qualification.Perform root cause analysis and implement corrective actions for process and equipment-related quality issues.Support internal and external regulatory audits.Qualifications:Minimum 3 years of validation experience.B.S. degree in a scientific field.Comprehensive understanding of product, equipment, and process validation.Experience applying risk management concepts and tools.Hands-on troubleshooting experience and knowledge of quality system standards.Strong written and verbal communication skills.Excellent teamwork and collaboration skills.Experience with GMPs, GCPs, GLPs, GAMP, and Part 11 compliance related to system qualification.Familiarity with Quality GxP IT compliance requirements.
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