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Curriculum Vitae
Personal Information
Name: Ala Awwad Elias Kakish
Birth: 10 April 1977
Nationality: Jordanian
Material: Married
Address
Resident: Amman – Jordan.
Mobile : +962 79 5 255366
E-mail : alakakish@yahoo.com
P.O. Box: 330320; Zip code 11134 Amman, Jordan
Education
 B.Sc. Chemistry, 2000, University of Jordan, Amman, Jordan.
 High School from Catholic school, June. 1995.
Professional training
• ISO 15189:2012 training certificate
• Dissolution Testing Bioequivalence & Bioavailability
• Introduction to clinical project management.
• Introduction to clinical research and ICH GCP for clinical trail
monitors
• Trail site management
• Project Management
• EU clinical trails directive
• ISO/IEC 17025:2005 Standard Field of Application and Requirements.
• Clinical Study in Jordan.
• Qualified service operator training on the API 5000 mass spectrometer
.
• GLP course.
1/5
• GCP course.
• Study director course.
• Regulatory Update for management of clinical trials
• An Introduction to Common Technical Documentation
• Review of Clinical Trial Documentation
• Enovation in Clinical Project management
• Risk based Management of Clinical Trials process
• Effective organization of Clinical Trials supplies.
• The GCP inspection Process
• Mass Spectrometer Training Course
Employment
• 2012_ present Sultan Medica Group “Sultan Central Laboratory”. Deputy Quality
Control Manager.
• 2009 – 2011 ClinicalQuest, AnaQuest. Assist in Establishing Clinical Trail Center
and Analytical Lab Services ‘Quality Assurance and Clinical Research
Associate.’
• 2007- 2009 Rum for Drug Evaluation and Research (PharmaquestJO)
Quality Assurance Manager. ‘Assist in Establishing Clinical and Analytical
Sites ‘
• 2000-2006 , Pharmaceutical Research Unit (PRU) / Royal Scientific Society
2005 –2007 Analytical Team Leader.
2003- 2004 Analytical Study Director.
2001- 2003 Senior Analyst.
2000 -2001 Analyst.
Responsibilities
2/5
 As a quality control in medical laboratories; I am responsible for preparing all
documents that related to the laboratory upon ISO 15189:2012.
 Preparing Standared Operation Procedure (SOPs) upon high standarizations
roles.
 Responsible for Sultan Medica Branches for quality control wize.
 Ensure that the instruments are updated mantinanced and calibrated.
 Responsible for the relation between the laboratory and MOH for quality
resoans.
 Responsible for external/internal quality control.
 Evaluate the reports and working flow in the laboratory.
 Preparing schedual audits for the central and branches.
 Ensure that the laboratory follow high standerizing for documentation and
reporting.
 Reporting the evaluations and the auditing reports to the general manager for
evaluation.
 Preparing for the external auditors/inspectors to evaluate the laboratory.
 Ensure that the laboratory under high stanarization ISO 15189:2012.
 I participated in coordenating the clinical part of biostudies , which intailes
working in a high regulated GCP and GLP invironments .
 Verify that the rights and well- being of human subjects are protected .
 Implementing and maintaining quality assurance system with written SOP’s to
comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
and the applicable regulatory requirement(s) .
 Ensure proper handling and storage of investigational product(s) for the trial
and documentation thereof .
 Ensure that the data are reliable and have been processed correctly .
 Checking the accuracy and completeness of trial-related records against each
other .
 Inspect the facilities, equipment, procedures and methods to ensure
compliance with GCP and GLP regulations .
 Ensure that trials are conducted and data are generated, documented, and
reported in compliance with the protocol, GCP and applicable regulatory
authorities .
3/5
 Ensure that the clinical trial protocols/ reports meet the standard of ICH
guidelines for structure and content .
 Preperation of biological samples (plasma or urin),
toward trace analysis of drugs in biological fluids.
 Method development for the analysis of several drugs and metabolites in
human plasma including analyte extraction, optimization of chromatographic
conditions, and optimization of detector settings, this have included but not
limited to HPLC with UV, Fluorescence, Diode array or Electrochemical
Detectors and GC (with FID or ECD) ,GC/MS and LC/MS/MS .
 Method validition according to international guidelines of regulatory
requirements bioanalytical method validation , and the analysis of drugs in
several matrices.
 Installation and calibration of the laboratory instruments and equipment.
 Production of the bioanalytical validation report , as part of the final biostudy
report which involves the use of statistics for analytical chemists .
 As a study director I simultaneously supervised six senior analysts and four
analysts . As a team leader I simultaneously supervised ten senior analysts .
Conferences
Poster present at the 2nd
International Conference of the Faculty of Pharmacy,
University of Jordan, Jordan, October 2001.
 Tutunji,M. F., Najjar, A. and Kakish, A. “Development and Validation of a
New High Performance Liquid Chromatographic Method with Pulsed Amperometric
Detection for the Determination of Sildenafil in Human Plasma .
Professional Skills
 Excellent experience in the use of common software including, MS Windows,
MS Excel, MS Word, MS PowerPoint, MS Outlook express and Internet
software and e-mail, with using all versions.
 Excellent in web search, for chemical information, instruments specifications,
scientific literature, as well as use of the sciences finder.
 Highly experienced in wet analytical chemistry, separation technologies which
includes HPLC (with UV, Fluorescence, Diode array or Electrochemical
Detectors) and GC (with FID or ECD) , GC/MS and LC/MS/MS .
 Good background in Polarographic techniques, and capillary Electrophoresis
instrumentation and applications.
 Familiar with BP (British Pharmacopeia), USP, ASTM (American Standard
Test Methods), GLP (Good Laboratory Practice), GCP (Good Clinical
Practice) , company SOP’s (Standard Operating Procedure) , FDA (Food &
4/5
Drug Administration) and ICH ( International Conference on Harmonization )
approval .
 Familiar with legal procedures and customs clearance.
Personal Skills
 Committed as a team player.
 Able to perform accurately under pressure.
 Excellent interpersonal relations with the abillity to clearly communicate with
others at all professional levels .
 Able to prepare technical presentations, seminars, and to prepare training
materials.
 High insensitive to upgrade and explore new and innovative endeavors.
 Maintenance of analytical and domestic instruments is one of my interests.
 Good sense of humor.
 Driving License.
5/5
Drug Administration) and ICH ( International Conference on Harmonization )
approval .
 Familiar with legal procedures and customs clearance.
Personal Skills
 Committed as a team player.
 Able to perform accurately under pressure.
 Excellent interpersonal relations with the abillity to clearly communicate with
others at all professional levels .
 Able to prepare technical presentations, seminars, and to prepare training
materials.
 High insensitive to upgrade and explore new and innovative endeavors.
 Maintenance of analytical and domestic instruments is one of my interests.
 Good sense of humor.
 Driving License.
5/5

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ala_cv 12.2014

  • 1. Curriculum Vitae Personal Information Name: Ala Awwad Elias Kakish Birth: 10 April 1977 Nationality: Jordanian Material: Married Address Resident: Amman – Jordan. Mobile : +962 79 5 255366 E-mail : alakakish@yahoo.com P.O. Box: 330320; Zip code 11134 Amman, Jordan Education  B.Sc. Chemistry, 2000, University of Jordan, Amman, Jordan.  High School from Catholic school, June. 1995. Professional training • ISO 15189:2012 training certificate • Dissolution Testing Bioequivalence & Bioavailability • Introduction to clinical project management. • Introduction to clinical research and ICH GCP for clinical trail monitors • Trail site management • Project Management • EU clinical trails directive • ISO/IEC 17025:2005 Standard Field of Application and Requirements. • Clinical Study in Jordan. • Qualified service operator training on the API 5000 mass spectrometer . • GLP course. 1/5
  • 2. • GCP course. • Study director course. • Regulatory Update for management of clinical trials • An Introduction to Common Technical Documentation • Review of Clinical Trial Documentation • Enovation in Clinical Project management • Risk based Management of Clinical Trials process • Effective organization of Clinical Trials supplies. • The GCP inspection Process • Mass Spectrometer Training Course Employment • 2012_ present Sultan Medica Group “Sultan Central Laboratory”. Deputy Quality Control Manager. • 2009 – 2011 ClinicalQuest, AnaQuest. Assist in Establishing Clinical Trail Center and Analytical Lab Services ‘Quality Assurance and Clinical Research Associate.’ • 2007- 2009 Rum for Drug Evaluation and Research (PharmaquestJO) Quality Assurance Manager. ‘Assist in Establishing Clinical and Analytical Sites ‘ • 2000-2006 , Pharmaceutical Research Unit (PRU) / Royal Scientific Society 2005 –2007 Analytical Team Leader. 2003- 2004 Analytical Study Director. 2001- 2003 Senior Analyst. 2000 -2001 Analyst. Responsibilities 2/5
  • 3.  As a quality control in medical laboratories; I am responsible for preparing all documents that related to the laboratory upon ISO 15189:2012.  Preparing Standared Operation Procedure (SOPs) upon high standarizations roles.  Responsible for Sultan Medica Branches for quality control wize.  Ensure that the instruments are updated mantinanced and calibrated.  Responsible for the relation between the laboratory and MOH for quality resoans.  Responsible for external/internal quality control.  Evaluate the reports and working flow in the laboratory.  Preparing schedual audits for the central and branches.  Ensure that the laboratory follow high standerizing for documentation and reporting.  Reporting the evaluations and the auditing reports to the general manager for evaluation.  Preparing for the external auditors/inspectors to evaluate the laboratory.  Ensure that the laboratory under high stanarization ISO 15189:2012.  I participated in coordenating the clinical part of biostudies , which intailes working in a high regulated GCP and GLP invironments .  Verify that the rights and well- being of human subjects are protected .  Implementing and maintaining quality assurance system with written SOP’s to comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and the applicable regulatory requirement(s) .  Ensure proper handling and storage of investigational product(s) for the trial and documentation thereof .  Ensure that the data are reliable and have been processed correctly .  Checking the accuracy and completeness of trial-related records against each other .  Inspect the facilities, equipment, procedures and methods to ensure compliance with GCP and GLP regulations .  Ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP and applicable regulatory authorities . 3/5
  • 4.  Ensure that the clinical trial protocols/ reports meet the standard of ICH guidelines for structure and content .  Preperation of biological samples (plasma or urin), toward trace analysis of drugs in biological fluids.  Method development for the analysis of several drugs and metabolites in human plasma including analyte extraction, optimization of chromatographic conditions, and optimization of detector settings, this have included but not limited to HPLC with UV, Fluorescence, Diode array or Electrochemical Detectors and GC (with FID or ECD) ,GC/MS and LC/MS/MS .  Method validition according to international guidelines of regulatory requirements bioanalytical method validation , and the analysis of drugs in several matrices.  Installation and calibration of the laboratory instruments and equipment.  Production of the bioanalytical validation report , as part of the final biostudy report which involves the use of statistics for analytical chemists .  As a study director I simultaneously supervised six senior analysts and four analysts . As a team leader I simultaneously supervised ten senior analysts . Conferences Poster present at the 2nd International Conference of the Faculty of Pharmacy, University of Jordan, Jordan, October 2001.  Tutunji,M. F., Najjar, A. and Kakish, A. “Development and Validation of a New High Performance Liquid Chromatographic Method with Pulsed Amperometric Detection for the Determination of Sildenafil in Human Plasma . Professional Skills  Excellent experience in the use of common software including, MS Windows, MS Excel, MS Word, MS PowerPoint, MS Outlook express and Internet software and e-mail, with using all versions.  Excellent in web search, for chemical information, instruments specifications, scientific literature, as well as use of the sciences finder.  Highly experienced in wet analytical chemistry, separation technologies which includes HPLC (with UV, Fluorescence, Diode array or Electrochemical Detectors) and GC (with FID or ECD) , GC/MS and LC/MS/MS .  Good background in Polarographic techniques, and capillary Electrophoresis instrumentation and applications.  Familiar with BP (British Pharmacopeia), USP, ASTM (American Standard Test Methods), GLP (Good Laboratory Practice), GCP (Good Clinical Practice) , company SOP’s (Standard Operating Procedure) , FDA (Food & 4/5
  • 5. Drug Administration) and ICH ( International Conference on Harmonization ) approval .  Familiar with legal procedures and customs clearance. Personal Skills  Committed as a team player.  Able to perform accurately under pressure.  Excellent interpersonal relations with the abillity to clearly communicate with others at all professional levels .  Able to prepare technical presentations, seminars, and to prepare training materials.  High insensitive to upgrade and explore new and innovative endeavors.  Maintenance of analytical and domestic instruments is one of my interests.  Good sense of humor.  Driving License. 5/5
  • 6. Drug Administration) and ICH ( International Conference on Harmonization ) approval .  Familiar with legal procedures and customs clearance. Personal Skills  Committed as a team player.  Able to perform accurately under pressure.  Excellent interpersonal relations with the abillity to clearly communicate with others at all professional levels .  Able to prepare technical presentations, seminars, and to prepare training materials.  High insensitive to upgrade and explore new and innovative endeavors.  Maintenance of analytical and domestic instruments is one of my interests.  Good sense of humor.  Driving License. 5/5