• Good Manufacturing Practices (GMP’s) and Good Laboratory Practices (GLP’s) guidelines. New Drug Applications (NDA) and Food and Drug Administration (FDA) regulations.
• Strong knowledge of United States Pharmacopeia (USP) and European Pharmacopeia (EP), wet chemistry and chromatography techniques.
• Technical expertise in (QA/QC) laboratory environment such as maintenance, calibration, and validation of instruments and developing programs.
• SOPs, Qualification and Validation Protocols IQ, OQ, PQ.