Experience

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  Acdima international trading

  Aug 2017 - now

  - Supervising laboratory works.- Review analytical methods provided by the Research and development departments , andformally agree on acceptance criteria before execution of the transfer protocol.- Review all test procedure and test reports.- Review all SOPs related to Lab and Periodically update laboratory document list.- Participate in developing CAPA and responsible for the CAPA implementation in theTesting lab.- Participate in the assessment of the impact of deviations on testing quality.- Responsible for Training and Evaluation of newly hired analysts and their ongoingQualifications- Responsible for Making Complete Equipment File to all laboratory equipment ( Calibration - Preventive maintenance - Unplanned maintenance - Performance monitoring and intermediate check )-Handling of OOS-OOT-OOE Results - Handling of Trend Analysis and Skip Testing Protocol - Ensures the establishment of the quality system and its maintenance in accordancewith the ISO/IEC 17025:2017 International Standards.- Perform calculations of the uncertainty Measurements - Communicate with internal customers, service providers and vendors.- Assisting the internal / external audits.- Ensure meeting of key timing commitments- Coordinate with Testing Lab Analysts in testing procedures- Establish Quality Control Program ( Internal and external ) and Review qualitycontrol program data.- Participate with laboratory staff in analysis of PT. Show less - Supervision of all tasks performed in finished products department.- Creation and revision of sop related to finished department.- Creation and revision of monographs, specifications, analytical worksheet andCertificate of analysis of finished products.- Management of HPLC Columns.- Handling OOS and OOT.- Responsible for Trend Analysis for Finished products via Minitab- Responsible for Performance verification test of dissolution.- Responsible for Revision of process validation, Cleaning validation and hold time study protocolsand analysis.- Responsible for Following up maintenance, calibration , Intermediate and daily check oflab instruments (HPLC – Balance – pH meter).- Responsible for Risk management in QC lab and perform risk and opportunity action plan.- Applying of 5S in Chemical lab- Analytical method Validation.- General knowledge about stability studies Show less - Performing complete physical and chemical analysis for (Solid-Ampoules-VialsAerosols) Dosage Form.- Residual solvents analysis via head space GC.➢ Using Following Instruments : - HPLC ( Agilent and Waters ) - Dissolution and Disintegration Tester - Hardness Tester3 - Friability Tester - pH and Conductivity meter - UV- Performing complete analysis For process validation, cleaning validation and holdtime study samples.- Standardization of working standard against reference standard- Daily Check of Balance and pH meter.- Creation of sop related to finished department.- Creation of monographs, specifications. Analytical worksheet and Certificate Ofanalysis of finished products. Show less

  • GLP Compliance Supervisor / Technical Manager

    Oct 2023 - now

  • Senior Quality Control Analyst

    Dec 2020 - Sept 2023

  • QC Finished product Analyst

    Aug 2017 - Dec 2020