Qualified Person (l. 68/99)

35

Limito, Italy
Qualified person status under art. 52 d.lgs. 219/2006
Gmp compliance for medicinal gases
Batch release authority for pharmaceutical products
The role involves releasing medicinal gas batches in strict compliance with Italian law and Good Manufacturing Practices

Job Summary

  • The role involves releasing medicinal gas batches in strict compliance with Italian law and Good Manufacturing Practices.
  • Candidates will collaborate with the Quality Unit to ensure zero customer complaints and zero documentary non-conformities.
  • This position requires active participation in regulatory inspections and the validation of critical instrumentation.

Matching Summary

The role involves releasing medicinal gas batches in strict compliance with Italian law and Good Manufacturing Practices.

Skills & Requirements

Must-have

  • Qualified Person status under Art. 52 D.Lgs. 219/2006
  • GMP compliance for medicinal gases
  • Batch release authority for pharmaceutical products
  • Annual Product Review (APR) preparation
  • Regulatory reporting to AIFA

Nice-to-have

  • Experience with industrial and food grade gas analysis
  • Waste management documentation support
  • Team collaboration in production planning
  • Problem-solving in non-conformity resolution

Key Requirements

  • Laurea in chemistry/pharmacy per Art. 52 D.Lgs. 219/2006
  • Professional registration and Qualified Person qualification
  • Minimum 2 years experience in medicinal quality control
  • Membership in professional register (Albo professionale)
  • Eligibility under Law 68/99 (Protected Categories)

Work Rights

Must be eligible under Law 68/99

Tailored Resume

Cover Letter