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Fortil

QA & GMP Non-Conformities Management Consultant

1w

Fortil

Aprilia, IT · Full-time · €35,000 – €50,000

About this role

Fortil is an international engineering and technology consultancy group based on an independent model, uniting over 2,500 employees. With 30 locations in 14 countries, it promotes entrepreneurial freedom and individual potential development. The QA & GMP Non-Conformities Management Consultant joins the Quality Assurance department to ensure products meet safety, efficacy, and quality requirements per regulations.

The role focuses on managing internal and external non-conformities, including deviations, OOS, and complaints. Daily tasks involve classification, investigations, root cause analysis, CAPA implementation and management, effectiveness monitoring, documentation drafting, and using document management software.

Inserted into the Quality Assurance team within an international group, the consultant works in a stimulating environment emphasizing regulatory compliance in pharmaceuticals. The position supports high standards in safety and quality for pharmaceutical products.

Fortil offers personalized support for skill growth and an ecosystem encouraging steps beyond the comfort zone. Employees gain opportunities to become shareholders, engage in community and non-profit projects, and benefit from parental support policies. The company commits to equal opportunities for all, including people with disabilities regardless of gender, origin, or sexual orientation.

Requirements

  • Specialist degree in Pharmacy, CTF, Biology, Chemistry or similar
  • At least 1 year of professional experience in the role, in pharmaceutical Quality Assurance, preferably sterile drug production
  • Excellent knowledge of RCA tools (5 Whys, Ishikawa diagrams, FMEA, Kipling)
  • Knowledge of cGMP and sector guidelines (FDA, ICH, Eudralex)
  • Good knowledge of English

Responsibilities

  • Manage internal and external non-conformities (deviations, OOS, complaints)
  • Classify non-conformities
  • Conduct investigations and root cause analysis (RCA)
  • Implement and manage corrective and preventive actions (CAPA)
  • Monitor effectiveness of actions
  • Draft documentation
  • Use document management software

Benefits

  • Personalized support for skill development
  • Ecosystem encouraging steps beyond comfort zone
  • Opportunity to become shareholder
  • Involvement in community and non-profit projects
  • Dedicated policy supporting parenthood
  • Equal opportunities regardless of gender, origin, sexual orientation, or disability