Quality Management System (QMS), ISO 9001, Good Manufacturing Practices (GMP) & Good Laboratory Practices (GLP). Wide knowledge in laboratory instruments (operation/calibration) such as HPLC, UV Spectrophotometer and Analytical Balances .. Etc., Excellent knowledge and experience in SOP Writing and reviewing as well as laboratory report and qualification protocols. Strong experience in USP, BP and EP Monographs as well as ICH Guidelines. Wide knowledge in laboratory testing regarded. Strong skills in R&D (drug formulation & analytical method development) as well as CTD file preparation.