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Quality Validation Specialist

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Alfasigma

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Location:
Italy , Pomezia

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

The new employee, reporting directly to the Quality Validation Coordinator, will be part of a team of 4 people. As a Quality Validation Specialist, 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.

Job Responsibility:

  • Ensure the implementation and ongoing maintenance of ALCOA / ALCOA+ principles throughout the entire GMP data lifecycle
  • Support and/or perform Data Integrity Risk Assessments (DIRA) on processes, equipment, and computerized systems
  • Evaluate and approve data governance controls, including access management, audit trails, backup, archiving, and data lifecycle management
  • Manage data integrity deviations and incidents, including the definition and follow‑up of CAPAs
  • Support regulatory inspections and audits as Data Integrity Subject Matter Expert (SME)
  • Perform 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 activities
  • Ensure documentation compliance with GMP requirements, Annex 11, and GAMP 5
  • Assess GMP impacts of change controls related to equipment and systems
  • Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
  • Collaborate with other Site Departments in order to achieve the goal of the company’s projects
  • Participate in calls/meetings with customers/clients to support the discussion on topics related to equipment qualification
  • Collaborate with the Engineering department to close on time all assigned project and review all the documents prepared by the qualification team
  • Support the Quality Compliance team in preparing Customer Audits and Regulatory inspections, providing necessary information and documentation

Requirements:

  • Master’s degree in industrial chemistry, Pharmaceutical Chemistry and Technology (CTF), Chemistry, Chemical Engineering, Biomedical Engineering or Automation Engineering
  • Knowledge of the main ALCOA+ principles
  • Knowledge of the key Data Integrity guidelines
  • Strong interpersonal and communication skills
  • Result‑oriented mindset with strong problem‑solving skills
  • Good organizational skills
  • Good knowledge of GMP Quality Systems
  • Minimum of 5 years working within pharmaceutical manufacturing
  • Strong command of the English & Italian languages, technical writing skills are a must
What we offer:
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development

Additional Information:

Job Posted:
May 19, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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