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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.
Name: Majed Mazen Abdul Kareem M.
Date & place of Birth: May , in Kuwait
* / 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:
* 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:
* 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..
* 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.
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.
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.
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 , .
* : Faculty of science Chemistry department Al Yarmouk university Jordan, B.Sc. Chemistry.
* : Irbid secondary school, Jordan
General secondary education, scientific stream.
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
Applicable on request