Jeddah, Makkah, Saudi Arabia
Proven track record with over 25 yrs experience in the operations of pharmaceutical quality control, and analytical research, at various positions as senior manager, manager, assistant manager and chemist in QC and R&D. Expert in product registration regulatory queries handling globally, well versed with QA systems, Key work areas: QC Testing, Stability Studies, Comparative dissolution profile (F2 factor), Shelf life extension, Audits & Compliance, Specifications, Test method, Technology Transfer, Method Validation, Training, Product Registration Facilitator, Handling of Regulatory queries, ERP System (SAP & Oracle), Visionary, Problem Solver, root casue analysis.
To manage operations of quality control in compliance to international regulations. Documentation (Specification of RM & FP, test methods, SOPs, Protocols, Reports). To ensure successful analytical technology transfer (Plant and international level). Stability testing of new products (exhibit batches) and exisiting products to meet registration requirements and compliance. Core Team member of SAP & Oracle Team - QC Module. Training of employees (training need analysis, training plan, training skill matrix) Equipment Control (Validation, DQ/IQ/OQ/PQ, Calibration, PM, LC Data system 21 CFR Part 11). Control of Reference Standards. To manage and keep QC Laboratory in compliance to US-FDA, EU, UK-MHRA, MCC, ICH, WHO, ISO 9001:2008, GCC and Saudi-SFDA. Successfully faced several international audits. Excecution and management of Comparative dissolution profile (F2) studies. Failure investigation (OOS/OOT), identify problems and propose remedial actions. Handling of queries from Regulatory bodies (MENA region) to facilitate product registration. Comparative dissolution profile (F2 factor) studies. Product shelf life extension.
Quality control of incoming materials, and finished pharmaceutical products, training, team building, Stability, Audits.
Development of Specifications and test methods of raw materials and finished products. Analytical Method Validation as per ICH and USP. Raw Material & Finished Product testing, to identify problems and trouble shooting. Control of equipments (Validation, IQ/OQ/PQ, Calibration) To support and handle regulatory queries from finished product registration (MENA region). Training of employees. Compliance to Regulatory Audits.
Quality Control testing, specifications, test method, QC systems.
Development of stability indicating assays in complex mixtures of dosage forms and nutritional supplements like multivitamin & herbal preparations, impurities and related substances tests by HPLC, GC and spectroscopy, validation and report preparation as per ICH guideline. To examine existing procedure and propose modification to improve cost, efficiency and safety, incorporate method changes and validate the method. To provide analytical support and profiles to formulation development and processes which meet product profile with expected quality, timing and budget. Stability Studies – Initiation, protocol preparation, sample analysis and stability study report preparation, as per ICH guidelines. Development of specifications for raw & packing materials and finished products. Writing and review of specifications and to obtain final approval. To author and review Standard Test Procedures (STPs), Standard Operating Procedure (SOP), Calibration Procedures and Validation Protocols. To validate the instruments, perform periodic calibration & maintain their records. Review of registration dossiers for MENA countries. To prepare response of regulatory queries for product approval.