Expertise in Pharmaceutical Manufacturing (solid & Liquid dosage forms), Facility design, equiptment machineries selection, production planning, scheduling, work allocation/distribution. Staff selection and assesing their skill and knowledge level. Sketch job responsibility and reporting format for various jobs. Thorough and hand on experience with formulation development by QbD principle, DOE. Indepth knowledge of stability studies. Expertise in analytical method development/Validation by (HPLC, UV/VIS, IR, etc). Fimiliar with all documentation requirement for dossier submission for WHO and other regulatory bodies. Justification of Formulation and Process with respect to QTPP/CQAs. Link...
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