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Summary

Expert in all r&d activity including Formulation & analytical Research aspects ...

Experiences

Current Experience

  • Reseach & Development section head (Officer)


    Since March 2016

Past Experience

  • Research & Development pharmacist ( Formulation & Analytical Research Dep.)

    April 2013 --- February 2016
    Formulation department : 1- supervise the Lab activities & ensure cGMP & ehs implementation. 2- provide scientific, technical and operational support of drug products development. 3- follow up the stock of api & excipiens in the Lab. 4- prepare sops & ensure technical & quality aspects. 5- prepare master formula & development report for registration file. 6- literature survey including: patent status – bcs – in-vivo, in-vitro assessment – api specification – excipients specification –Packaging suitability. 7- pre-Formulation studies including: api Characterization – compressibility Testing – crystalinity - polymorphism – api & excipient compatibility Testing using dsc , HPLC . 8- formulate & develop the Formulation process of solid dosage forms of Pharmaceutical products. 9- identify ingredient dependent issues within Formulation & processes. 10- analyze, follow up and summarize the trials results. 11- costing of the material quantities and man - machines hours for each trial. 12- determine suitable primary & secondary Packaging tools for new products. production department (pilot stage ) 1- prepare bmr & bpr for pilot batches scale 2- ensure following up sops to fully implement the Compliance to cGMP & ehs. 3- set up the parameters of the machines in the production to facilitate an easy transfer of the Pharmaceutical products from R&D Lab. 4- set up qbd science)" rel="nofollow">Protocol & follow up its implementation. 5- provide direction, correction & motivate the operators to achieve the target quality at time schedule. 6- manage the scientific, technical and operational trouble shootings occur. 7- calculate overall equipment effectiveness (oee) involving calculate availability , performance & quality factors .

  • Research & Development Pharmacist

    September 2012 --- March 2013
    1- Analysis of R&D Formulation samples of different forms using different types of HPLC (alliance-breeze-shimadzu) , acquity uplc waters, gc , UV Spectroscopy apparatuses & Titration methods. 2- formulate & develop the Formulation process of different forms of Pharmaceutical products . 3- identify ingredient dependent issues within Formulation & processes . 4- provide scientific, technical and operational support of drug Product Development. 5- stability & methodology : a) – Analysis of stability samples including their related substances . b) – making stability indicating methods & making forced degradation methods for different forms of Pharmaceutical products. c) – making stability studies of different forms of Pharmaceutical products in various conditions of temperature & humidity. 6- making Validation of the Analytical methods . 7- establish & develop new Analytical methods for Analysis of different forms of Pharmaceutical preparations. 8- making biowaiver studies according to FDA guidance . 9- management of of trouble shooting in different apparatuses with time Planning schedule. 10- writing general, instrumental, chemical sops with full implementation & ensuring Compliance to glp. 11- preparing different types of Testing & volumetric solutions and adjust the requires factors according to usp.

  • Analyst & Formulator

    January 2011 --- August 2012
    1- participate in the start up of the Lab . 2- Analysis of qc finished & raw material of different forms using different types of HPLC (alliance-breeze-shimadzu) , acquity uplc waters, gc , UV Spectroscopy apparatuses & Titration methods. 3- formulate & develop the Formulation process of different forms of Pharmaceutical products . 4- identify ingredient dependent issues within Formulation & processes . 5- provide scientific, technical and operational support of drug Product Development. 6- stability & methodology : a) – Analysis of stability samples including their related substances . b) – making stability indicating methods & making forced degradation methods for different forms of Pharmaceutical products. c) – making stability studies of different forms of Pharmaceutical products in various conditions of temperature & humidity. 7- making Validation of the Analytical methods . 8- establish & develop new Analytical methods for Analysis of different forms of Pharmaceutical preparations. 9- making biowaiver studies according to FDA guidance . 10- management of of trouble shooting in different apparatuses with time Planning schedule. 11- writing general, instrumental, chemical sops with full implementation & ensuring Compliance to glp. 12- preparing different types of Testing & volumetric solutions and adjust the requires factors according to usp.

  • Stability & Methodology pharmacist

    August 2009 --- December 2010
    1- Analysis of R&D Formulation & stability samples of different forms using different types of HPLC (alliance-breeze-shimadzu) , acquity uplc waters, gc , UV Spectroscopy apparatuses & Titration methods. 2- stability & methodology : a) – Analysis of stability samples including their related substances . b) – making stability indicating methods & making forced degradation methods for different forms of Pharmaceutical products. c) – making stability studies of different forms of Pharmaceutical products in various conditions of temperature & humidity. 3- making Validation of the Analytical methods . 4- establish & develop new Analytical methods for Analysis of different forms of Pharmaceutical preparations. 5- making biowaiver studies according to FDA guidance . 6- management of of trouble shooting in different apparatuses with time Planning schedule. 7- writing general, instrumental, chemical sops with full implementation & ensuring Compliance to glp. 8- preparing different types of Testing & volumetric solutions and adjust the requires factors according to usp.

Personality

Self Assessment :
OrientationTrustApproachability

Knowledge

LinkedIn Assessment :
HPLCFDAValidationTitrationColumn ChromatographyUV-VisTLCSpectrophotometrypH meterDissolutionUVLCChromatographyIRgas chromatographyAnalytical ChemistryQCDrug DiscoveryscienceGLPcGMPSOPQuality ControlCAPAFormulationQuality SystemUV/VisPharmaceutical IndustryRegulatory RequirementsPharmaceuticsQuality AuditingUSPDrug DevelopmentLaboratoryStandard Operating Procedure (SOP)SOPGMP

Skills and Expertise

Self Assessment :
Analyze data Analytical skills Build and manage the Trial Master File (TMF) Build the CMC development plan Create SOPs Develop protocols Control data

Education

  • Bachelor of pharmaceutical science in pharmacy from Faculty of pharmacy Zagazig University in 2009

Training and Certification

  • IRCA approved Iso 9001/2008 QMS Lead Auditor in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Arabic
Full Proficiency
English
Full Proficiency

Area / Region

Saudi Arabia

Others

Driving License
  • Yes

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