Have 23 years’ experience in pharmaceutical industries, working in all pharmaceutical departments, mostly as QA\QC director for 6 years R&D manager for 13 years, and 3 years researcher in Jordan university, B.SC, Chemistry, Master MBA, and PMP professional and member in PMI, head of committees for usFDA and EU Audits, prepared the gap analysis, prepared the plan for complete the QMS with time line, and the companies got the FDA and EU approval.
Participating with the high management in different companies committees in setting short med and long-term business strategies for achieving the company’s objectives, and feasibility studies for the wish list of products to be approved for R&D stage.
Developed products from scratch solid dosage forms, semi-solid, liquid, sterile, oncology products, also have the knowledge for super generic and Biosimilar products, the development done for all stages, literature survey, method developments and validation, lab trials, optimum formula, pilot batches with process validation stability and prepared the bio-batch (cover all critical factors effect on the bioavailability to be close to originator) BE conducted and passed.
Quality Management system preparation from scratch to be equivalent with US or EU QMS.
Quality by design with all requirements as per US and EU regulatory Guidelines, we prepared summery for QbD, also prepared the training material for QbD.
Evaluation and qualification for new pharmaceutical factories, also the existed factories to be equivalence to US or Europe requirements.
R&D establishment from scratch.
Training for GMP, GLP, QbD, R&D and staff personality development.
Prepared the registration files and submitted to MENA, US, and Europe.
Prepared the strategic plan and the pipeline plan for R&D and all technology transfer from japan, US, and Europe.
-Controlling the financial performance of the Department and keep it within the set budget.
-Setting, cascading and communicating Key Performance Indicators (KPIs) for monitoring the performance of all departments’ staff.
Conducted many consultations with trouble shootings for pharmaceuticals and vet companies in MENA market (select the high quality with law cost solutions).