Description
QUALIFICATIONS * Currently working toward the Regulatory Affair Certificate. * Extensive analytical characterization and data interpretation skills. * Experienced in very different analytical tests like Assay, Release Rate, Residual Solvents, Water Content Determination, and ID by IR, and Viscosity Testing. * Expert in handling different analytical apparatus like HPLC, GC, FTIR, UV-VIS, Karl Fisher, Colorimeter, pH meter, Lab Centrifuge, Analytical Scale, Optical Microscope, Particle counter, Conductivity meter. * Familiar with compliance requirements within cGMP, safety and regulatory environments. * Experienced supervising entry-level analysts and interns in the QC Department. * Exceptional observational and analytical behavior. * Familiar with analytical methods and pharmaceutical industry regulations (GMP, GLP, & ICH, US Pharmacopeia, EP, ISOs). * Assistant of Lab Manager in QC and R&D Laboratories. * Experience troubleshooting laboratory instrumentation and simple repairs as needed. * Familiar with Controlled Drug Substances.