What we need:
Hands-on HACCP Program leadership
FMEA, PFMEA, DFMEA facilitation
Deep knowledge of EU GMP Annex 1 & CCS
Regulatory expertise: ISO 14971, 13485, 21 CFR, ICH Q9
A problem-solver who can lead investigations and drive CAPAs
Bachelor's + 5-8 years in Pharma, Biotech, or Medical Device