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