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<pre>Array ( [var] => cut_url ) </pre> Resume for Majed M. for Quality Assurance / Control / Chemicals & Petro-Chemicals in amman, Jordan. Search More Resumes for Quality Assurance / Control on Resumark.com #D9MXOX3B6
 

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Resume for Majed M. for Quality Assurance / Control / Chemicals & Petro-Chemicals in amman, Jordan




Occupation: Quality Assurance / Control Industry: Chemicals & Petro-Chemicals
Country: Jordan City: amman
State: Amman ZIP: 11101



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About me: Specialist in: cGMP, cGLP, FDA Requirement, Quality Control QC, Quality Management system QMS, Quality improvement QI, Quality Auditing QA, Total Quality management TQM, Regulatory requirements RA, Pharmaceuticals. PERSONAL INFORMATION: Name: Majed Mazen Abdul Kareem M. Date & place of Birth: May , in Kuwait Nationality: Jordanian Email: & Phone: + EXPERIENCE: * / present : ALHIKMA Pharmaceutical industries Co Amman Jordan QC SeniorSupervisor; QC senior compliance/data review Raw materials, LC, wet and packaging material, Hikma American FDA approval team Hikma Audits preparing team: Europe, JFDA, Saudi, Tunisia, South Africa, Eritrea, Slovakia ...etc. * / Now: Hikma QC senior compliance/Data Reviewer: Main Duties: * To provide Quality Control Technical and Compliance Data review support to the Quality Control department. * To ensure compliance through conducting technical and compliance reviews second person verification of QC raw data from raw material, inprocess, final product, stability, method qualification and test results. * Communicate and resolve corrections with a wide range of operators across several shifts. * Check and sign on notebooks/raw data. * Check and sign on instruments HPLC/GC...etc, performance qualification IQ, OQ, PQ. * Check and sign on instruments calibration data * Check and sign on certificates of analysis COA&;s. * / /: Hikma QC Team leader/ supervisor: Main duties: * Review and check the daily raw data generated under supervision. * Plan and distribute the daily routine work and day to day activities. * Create and follow out of specification investigation procedure for any OOS result&;s obtained in the routine analysis testing in order to perform proper investigation and follow up. * Perform proper training for employee. * Perform trend analysis. * Ensure cGMP and safety compliance. * Ensure that employee follow SOP&;s. * Update or create standard operating procedures SOP&;s, specification sheets and method of testing. * Review and check the calibration data. * Review and check the sampling. * Release / quarantine / reject materials. * Check and signing off on COA. * Follow up samples received from purchasing and reserve samples of raw materials. * Coordinate with outside laboratories. * Track testing and coordinate with other supervisors. * Supply analysts with test method and blank specification sheet. * Perform annual reviews of SOP&;s * Carry out performance evaluation. * Perform continues internal auditing on quality control system to assure compliance with cGMP, cGLP&;s, safety requirements and other quality control activities. * Evaluate and approve the new vendors for raw materials and reduce testing programs. * Results recording and checking on SAP computer system. * Release/ reject batches though SAP system. * Follow up on analytical trouble shooting. * Check the availability of all required items needed for analysis columns. Reagents...etc. * Follow up on working standards standardization. * Follow up and check on usage logbooks/receiving. * Generate vendor testing. * / /: Hikma QC Analyst Raw Material HPLC, GC, Atomic, wet, Package...Etc.. Main duties: * Implement standard operating procedure. * Perform all desired tests physical and chemical * Result recording on SAP computer system * Perform calibration and instruments qualification protocols IQ, OQ, PQ. * Follow system documentation system requirements. * Perform sampling verification. * Follow and preparing reagent solutions and other analytical requirements. * Take all required activities to work in compliance with cGMP, cGLP, and safety requirements. * Create and update MOA&;s and COA&;s. * Water treatment unit monitoring, testing, preparing water testing reports. * / / MIDDLE EAST Pharmaceutical industries Co. AmmanJordan. QC Analyst production & Raw Material :: Chemical testing of finished products and Raw Material samples including Assay and Dissolution testing using HPLC, UV, IR. :: Physical testing such as loss on drying, water content, density..etc, testing. :: Wet chemistry testing such as Heavy Metals, identification, Inorganic tests for Raw Materials Samples. :: Water treatment unit control and testing. :: Analytical methods development for HPLC and UV methods. :: Issuing analytical methods and method validation reports. SKILLS and Activities: * Total Quality Management theory, application and tools customer satisfaction, supplier partnership, leadership...etc.; Certified from Talal Abu Ghazaleh College. * Quality management system QMS and quality Risk management. * Qualification and Approval of new Vendors. * Lean thinking projects leader in "Reduce Waste and Boost Your Profit with Effective S program in QC Labs". * Reduced testing good experience and practice. * Responsible on purchasing, Searching of new instrument&;s and techniques, and receive offers from instruments suppliers. * cGMP&;s & GLP&;s: High knowledge, practice and training of current good manufacturing / laboratory practices. * High knowledge on American FDA requirements, Europe, JFDA, Saudi, Tunisia, South Africa, Eritrea, Slovakia ...etc. Requirements. * Out of specification OOS and variances report&;s following, and approval. * Sufficient knowledge on Regulatory affairs requirements. * V. Good knowledge in SAP. * Raw Material Receiving, Sampling, Approval High knowledge according to FDA and GMP. * High knowledge Water treatment system. * Standard Operating Procedure SOP&;s, create, Modify, and Training. * CFR Requirement&;s knowledge and practice. * IQ/OQ/PQ report&;s following and auditing. * Team Leader and Result&;s oriented. * Languages: Arabic mother language and English read, right, speaking / v.good * IT skills: * SAP, Windows, Microsoft office, ChemOffice excellent knowledge. * Laboratory and personal safety high knowledge and practices. * Pharmacopeia: High knowledge, practice, and understand of the requirements of: * United State Pharmacopeia USP * European Pharmacopeia EP * International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH * British Pharmacopeia BP * Japanese Pharmacopeia JP. * Instruments: High knowledge and Trained in Operating, Maintenance, Calibrating, and trouble shooting in the following instruments: * Gas Chromatography GC shimadzu GC * Atomic absorption Spectroscopy Shimadzu AA, AA, AA * HPLC Varian, Shimadzu LC, Waters * Total Organic Carbon TOC Shimadzu * Near Infrared PHAZIR Polychromix * Infrared Shimadzu, Thermo ...etc. * Particle size Analyzer Malvern Mastersizer * Others titrators, melting point, Refractometer...etc. CERTIFICATS AND COURSES: * Total Quality Management, application and tools customer satisfaction, supplier partnership, leadership,...etc., Certified from Talal Abu Ghazaleh College German university in Jordan, // to //. * Essential of Applied statistics Course; Certified from German Jordanian University, // till //. * TOEFL certificate, University of Jordan, May . * Lean thinking workshop and projects in "Reduce Waste and Boost Your Profit with Effective S program in QC Labs" January to April , * cGMP, cGLP courses, and training. * Focus on speaking course, British council, Jordan, July to September . * Continuous Courses in human engineering courses, soft skills. * Atomic Absorption Spectroscopy instrument theory, operating, and maintenance, in Shimadzu Middle East and South Africa center, IstanbulTurkey // to //. * Practical applications of General Chapter <> USP Residual solvents, via Dr Val Feyns U.S Pharmacopeia, March , . EDUCATION: * : Faculty of science Chemistry department Al Yarmouk university Jordan, B.Sc. Chemistry. * : Irbid secondary school, Jordan General secondary education, scientific stream. RESEARCH: second semester yarmouk university, Jordan "Formation and Entrapment of Noble Metal Clusters Ru II, Pt IV, Ag in Silica Aero gel Monoliths by chemical reaction" Professional Advisor: Ph.D. Abdel Monem Rawashdeh, Yarmouk University REFERENCES: Applicable on request

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