Job Title: Quality Specialist
Location: Guidonia Montecelio, Italy
Responsibilities:
* 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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