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Mohammed Hakami Pharmacist

Saudi arabai

Senior Pharmacist, Pharmaceutical Raw Materials
Since June 2014, Riyadh
 Verifying assessment decisions on drug substances conducted by subordinate pharmaceutical assessors, ensuring national standards are maintained and assessment needs of candidates are being met.
 Liaising with the other departments to ensure progress and conclusion of the application within the agreed upon time frame.
Pharmacist at the Executive Directorate of Products Evaluation and Standards Setting:
June 2012 – May 2015 (2 years) Riyadh
 Evaluation of quality parts of medicinal products’ applications ensuring they meet both national and international standards. This covers quality of raw materials, finished products and analytical procedures with their validations.
 Reviewing and evaluating post-approval variations’ files which cover many quality aspects of pharmaceutical products
 Reviewing and evaluating registration applications of pharmaceutical products applied to GCC. Evaluation of renewal dossiers of pharmaceutical products.
 Manage own workload working in conjunction with coordinators and other assessors to meet authority’s deadlines.
 Strong understanding of SFDA guidelines and current thinking of the organization in addition to other guidelines of international authorities such as FDA, EMA, Health Canada, ICH and WHO.
 Quality audits (GMP inspection) conducted by SFDA on pharmaceutical plants as I have participated in one of audit in Jordan December 2014