Manufacturing System Validation - Pharma (Hybrid, Summit West, NJ)
5 months ago
Summit
Sound understanding of Electronic Batch Records (EBR), Review by Exception (RBE), and Recipe Authoring/Validation. Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles ...