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Ehab Abu El-enein Abdel Kader

Quality Assurance Head & Audit T. Leader

Nasr City, Cairo, Egypt

Work Experience

  • Quality Assurance SDF & Sterile Sections HeadFull Time

    EVA pharma/Armanious Group

    Oct 2014 - Present -10 yrs, 9 months

    Egypt , Cairo

    • Job Details:** KEY ACCOUNTABILITIES: * Develop, implement and maintain effective Quality system, protocols and SOPs that ensure operations are in full compliance with corporate QMS, GDP and regulatory requirements. * Establish, develop and maintain validation master plan for production facilities, utilities, machinery and systems, including laboratory instrumentation. * Ensure effectiveness of change control process, manage all planned changes, ensure that all potential risks are captured and assessed. * Follow-up CAPA plans and ensure adequate handling & effective closure. * Maintain computerized system validation in compliance with GAMP. * Develop and introduce sterile related testing and examination activities within quality control laboratories. * Ensure and follow up cleaning validation process of production machine. * Responsible for inspecting outsourcing sterile manufacturing facilities by conducting site auditing as Quality auditor prior contracting process and follow up toll manufacturing process. ** KEY ACHIEVEMENTS: * Review and ensure compliance of conceptual sterile facility designs with cGMP. * Review sterile machines URS and develop related protocols. * Travel & conduct FAT, SAT, IQ, OQ, PQ and process validation of sterile facility. * Sterile facility project management. * Achieve effective commissioning and start-up of the first EVA Pharma two sterile production lines. * Perform several quality audits over outsourcing sterile manufacturing facilities. * Develop production and quality processing to be complied with EMEA and ready for accreditation. * Introduce Isolator and VHPs system technologies, developing and executing related qualification protocols of Microbiology isolator and production VHPs pass boxes.
  • Quality Control/Microbiology Certified Manager (ISO 17025)Full Time

    EVA pharma/Armanious Group

    Jan 2012 - Sep 2017 -5 yrs, 8 months

    Egypt , Cairo

    • Job Details:** KEY ACCOUNTABILITIES: * Responsible for making decisions concerning policy, resources and suppliers qualification. * Setting and monitor budget and CAPEX to ensure process sustainability. * Responsible for ensuring that testing activities meet the requirements of the EVA PHARMA customers, and regulations of ISO/IEC 17025:2005. * Implementation, maintenance, and improvement of the management system and to initiate actions to prevent or minimize any departures from the management system. * Reviews the executed manufacturing batch records for completeness, correctness, compliance of in-process control results with specification and reporting of “unusual incidents”. * Responsible for tracking and trending of out-of-specification results, failure investigation, non conformance, deviations, change controls and complaints. * Ensure that, all references & management system documentation are the latest version. * Responsible for the technical operations of the laboratory. Resources for training, laboratory methods, and measurement traceability are described in sections of manual and related procedures. ** KEY ACHIEVEMENTS: * ISO 22000 HACCP & ISO 17025 Full responsibility accreditation. * EMA accreditation over Haram Facility. * Oversee Saudi FDA regulatory commitments. * Horus 10th of Ramadan Quality laboratories project management & Facility qualification. * EVA Quality Center project conceptual designing, reviewing, commissioning and qualification (Facility, HVAC, Utilities, Machinery and related protocols) * Non-sterile operation planning responsible member.
  • Quality control/Microbiology SupervisorFull Time

    EVA Pharma

    Dec 2008 - Jan 2012 -3 yrs, 1 month

    Egypt , Cairo

    • Job Details:** KEY ACCOUNTABILITIES: * Supervises day to day operation of the Quality Control and Validation & methodology sections, including scheduling of manpower resources, review and approval of product releases, employee training, and testing support. * Develop complete departmental system to comply with ISO 17025 standards. * Prepares Standard operating procedure, Standard test procedure and approval of change control for them. * Manages procurement process of all materials required for analysis to prevent any stock rupture. * Oversees and coordinates daily prioritization of QC testing including scheduling of staff, equipment and lab productivity assessments. ** KEY ACHIEVEMENTS: * ISO 14000 & OHSAS 18000 Accreditations. * EVA Cosmetics Microbiology laboratories project management & facility qualification.
  • Quality Control SpecialistFull Time

    EVA Cosmetics (FMCG)

    Dec 2007 - Dec 2008 -1 yr

    Egypt , Cairo

    • Job Details:** KEY ACCOUNTABILITIES: * Maintains compliance with current GLPs, validation/qualification and training. * Conducts and follows up variety of QC testing and examination of finished products & Raw materials. * Performs sampling and microbiological examination of raw materials and packaging materials. * Troubleshoots and resolves operations issues. * Calibrates instruments according to work instructions to ensure compliance to standards. * Validates assay methods of finished products to ensure products’ compliance to standards. * Isolates and identifies microorganisms by microscopic examination, morphological characteristics and biochemical reactions. * Participates in validation of facilities and manufacturing processes to ensure compliance to standards. * Shares in quality improvement process.
  • Education

    • DBA in Strategic Management

      Ain Shams University (ASU)

      Jan 2015 - Jan 2018 - 3 yr

    • MBA in Business operation & project Management

      ESLSCA Business School

      Jan 2012 - Jan 2014 - 2 yr

    • MSc in Quality Management

      Arab Academy for Science, Technology and Maritime Transport (AAST)

      Jan 2010 - Jan 2012 - 2 yr

    • College Diploma in Physiology & Biochemistry

      Suez Canal University (SCU)

      Jan 2007 - Jan 2008 - 1 Year

    Achievements

    Training at Ain Shams University Special Hospital. Training at National Research Center.

    Skills

    • Microsoft Office
    • Quality Control
    • Quality Assurance
    • Microbiology
    • Academic and professional trainer
    • Project Management
    • Microsoft Project
    • Planning
    • Supply Chain
    • Oracle
    View More

    Languages

    • Arabic

      Fluent
    • English

      Fluent
    • French

      Advanced

    Training & Certifications

    • Quality Auditor (ISO 9001:2015)

      Bureau Veritas (Professional Certification)·2017
    • Managing change

      Mindleaders ·2013
    • Innovation in the work place

      Mindleaders ·2013
    • Problem Solving Through Productive Thinking

      Mindleaders ·2013
    • Project Management Professional (PMP)

      Mindleaders·2013
    • Stress Management

      Mindleaders ·2013
    • Six Sigma

      Mindleaders·2013
    • Time management for maximum productivity

      Mindleaders ·2013
    • Certified Business Analysis Professional - CBAP (v2)

      Mindleaders·2013
    • Quality Auditor (ISO 22000:2005)

      Target·2012
    • Oracle application quality manager developers & users

      Oracle·2010
    • Process validation for analytical chemistry

      EQE·2010
    • Quality Auditor & Uncertainty measurement expert (ISO/IEC 17025:2005)

      Engineering and quality experts·2009
    • Corrective and preventive actions

      EQE·2009
    • GLP and Microbiological examination and validation techniques

      EQE·2009
    • Design and qualification of clean room systems for optimized domination of contamination risks;

      Dr. Hans Schicht·2009
    • Quality Auditor (ISO 14001:2004), (OHSAS BS 18001:2007)

      Engineering and quality experts (EQE)·2009
    • Performance Management Expert

      Dale Carnegie·2009
    • Process Validation

      Pharma Mix·2008
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