Full TimeENEurope
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.
Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.
But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.
Responsibilities:
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.
Data Integrity
- 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)
Equipment Qualification Documentation Review
- 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.
Specific Skills, Educational Requirements and Experience
- 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
Why Join Alfasigma:
At 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.
