
Ehab Abu El-enein Abdel Kader
Quality Assurance Head & Audit T. Leader
Nasr City, Cairo, EgyptWork 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 SchoolJan 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
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Languages
Arabic
FluentEnglish
FluentFrench
Advanced
Training & Certifications
Quality Auditor (ISO 9001:2015)
Bureau Veritas (Professional Certification)·2017Managing change
Mindleaders ·2013Innovation in the work place
Mindleaders ·2013Problem Solving Through Productive Thinking
Mindleaders ·2013Project Management Professional (PMP)
Mindleaders·2013Stress Management
Mindleaders ·2013Six Sigma
Mindleaders·2013Time management for maximum productivity
Mindleaders ·2013Certified Business Analysis Professional - CBAP (v2)
Mindleaders·2013Quality Auditor (ISO 22000:2005)
Target·2012Oracle application quality manager developers & users
Oracle·2010Process validation for analytical chemistry
EQE·2010Quality Auditor & Uncertainty measurement expert (ISO/IEC 17025:2005)
Engineering and quality experts·2009Corrective and preventive actions
EQE·2009GLP and Microbiological examination and validation techniques
EQE·2009Design and qualification of clean room systems for optimized domination of contamination risks;
Dr. Hans Schicht·2009Quality Auditor (ISO 14001:2004), (OHSAS BS 18001:2007)
Engineering and quality experts (EQE)·2009Performance Management Expert
Dale Carnegie·2009Process Validation
Pharma Mix·2008