Qa & Gmp Non-conformities Management Consultant

Fortil Group

Lazio, Italy
**
Internal and external non-conformity management
Root cause analysis using 5 whys and ishikawa
Capa implementation and effectiveness monitoring
** Fortil Group is seeking a QA & GMP Non-Conformities Management Consultant in Lazio, Italy, to ensure that products meet safety, efficacy, and quality standards. The ideal candidate should have a relevant degree and experience in quality assurance within the pharmaceutical industry. **

Job Summary

  • The consultant will ensure products meet safety, efficacy, and quality requirements under current regulations.
  • Key responsibilities include managing deviations, out-of-specification results, complaints, and conducting root cause analyses.
  • Fortil offers a supportive ecosystem with opportunities for personal growth, employee ownership, and community involvement.

Matching Summary

Match Score: 75

** Fortil Group is seeking a QA & GMP Non-Conformities Management Consultant in Lazio, Italy, to ensure that products meet safety, efficacy, and quality standards. The ideal candidate should have a relevant degree and experience in quality assurance within the pharmaceutical industry. **

Skills & Requirements

Must-have

  • Internal and external non-conformity management
  • Root cause analysis using 5 Whys and Ishikawa
  • CAPA implementation and effectiveness monitoring
  • cGMP and FDA/ICH/Eudralex regulatory knowledge
  • Documentation writing in English

Nice-to-have

  • Experience in sterile pharmaceutical production
  • FMEA and Kipling method expertise
  • Stakeholder engagement skills
  • Commitment to continuous improvement

Key Requirements

  • Specialist degree in Pharmacy, CTF, Biology, or Chemistry
  • Minimum 1 year experience in Pharmaceutical Quality Assurance
  • Proficiency in RCA tools like FMEA and Ishikawa diagrams
  • Strong knowledge of cGMP and international guidelines (FDA, ICH, Eudralex)
  • Fluent English language skills

Work Rights

Not specified

Tailored Resume

Cover Letter