ResponsibilitiesThe new employee, reporting directly to the Quality Validation Coordinator, will be part of a team of 4 people. As a Quality Validation Specialist, they will play a crucial role in ensuring compliance with GMP requirements by supporting data integrity governance and equipment qualification activities. This role will contribute to maintaining the validated state of GMP systems and equipment, ensuring regulatory compliance, and supporting continuous improvement initiatives across the site.Data IntegrityEnsure the implementation and ongoing maintenance of ALCOA / ALCOA+ principles throughout the entire GMP data lifecycleSupport and/or perform Data Integrity Risk Assessments (DIRA) on processes, equipment, and computerized systemsEvaluate and approve data governance controls, including access management, audit trails, backup, archiving, and data lifecycle managementManage data integrity deviations and incidents, including the definition and follow‑up of CAPAsSupport regulatory inspections and audits as Data Integrity Subject Matter Expert (SME)Equipment Qualification Documentation ReviewPerform critical QA review and approval of equipment qualification documentation, including: User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Qualification reports and requirements traceability, Periodic requalification activitiesEnsure documentation compliance with GMP requirements, Annex 11, and GAMP 5; assess GMP impacts of change controls related to equipment and systemsParticipate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)Collaborate with other site departments to achieve the goal of the company’s projectsParticipate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualificationCollaborate with the Engineering department to close on time all assigned projects and review all the documents prepared by the qualification teamSupport the Quality Compliance team in preparing customer audits and regulatory inspections, providing necessary information and documentationSpecific Skills, Educational Requirements and ExperienceMaster’s degree in industrial chemistry, Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, Biomedical Engineering or Automation EngineeringKnowledge of the main ALCOA+ principlesKnowledge of the key Data Integrity guidelinesStrong interpersonal and communication skillsResult‑oriented mindset with strong problem‑solving skills and good organizational skillsGood knowledge of GMP Quality SystemsMinimum of 5 years working within pharmaceutical manufacturingStrong command of the English & Italian languages; technical writing skills are a mustWhy Join AlfasigmaAt Alfasigma, we foster a culture where the courage to innovate is key to our success.We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.Join Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry.#J-18808-Ljbffr