Experience

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  PHARMACEUTICAL CONTRACTORS

  • South Africa
  • Pharmaceutical Manufacturing
  • 1 - 100 Employee

  • Quality Assurance Compliance and Validation Officer

    • 2022 - Present

    • Preparation of standard operating procedures as per USP, Ph.eur/BP, PICS and WHO guidelines.• Preparation of laboratory analytical methods and protocols as per pharmacopeia monographs and SAHPRA dossiers.• Technical site transfer gap analysis and method comparison, Site transfer protocol compilation.• Out of specification report compilation.• Equipment calibration and calibration management • Equipment performance qualification protocols compilation.• Cleaning validation protocol creation and execution.• Investigation lead for production and laboratory OOS.• Formulation of bulk products.

  • Quality Control Compliance Officer and Supervisor

    • 2019 - 2022

    • Administrator duties for QC and Microbiological laboratory. • Ensure GLP and SAHPRA requirements are adhered to with regards to all laboratory activities• Managing and designing reporting structures including data sources, security and metadata.• Preparation of standard operating procedures as per USP, Ph.eur/BP, PICS and WHO guidelines.• Preparation of laboratory analytical methods and protocols as per pharmacopeia monographs and SAHPRA dossiers.• Environmental monitoring program lead, as per WHO, USP, PICs and ISO guidelines.• Reagent and consumables stock management and procurement.• Equipment URS compilation and ordering.• Laboratory analysis; raw materials and bulk using HPLC, GC, AA and UV amongst other physical testing equipment.• Technical site transfer gap analysis and method comparison, Site transfer protocol compilation.• Out of specification report compilation.• CoA compilation. • Reference standards management and qualification.• Equipment calibration and calibration management • Equipment performance qualification protocols compilation.• Cleaning validation protocol creation and execution.• Sample receiving, logging and issuance.• Analytical worksheet master document control.• Audit leading and audit feedback; CAPA creation and implementation.• Formulation of bulk products.• Analyst training and technical assistance.

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  Self-employed

  • Clinical Psychologist and Medico-legal Report Editor

    • 2019 - 2020

    • Biographical data capture• Proofreading and editing• Formatting of documents

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  EPIK (English Program in Korea)

  • English Educator

    • 2018 - 2019

    • Preparation of lesson plans• Presentation of English lessons

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  TaLK Program, Korea

  • English Educator

    • 2017 - 2018

    • Preparation of lesson plans• Presentation of English lessons

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  University of Pretoria/Universiteit van Pretoria

  • Tutor and Marker

    • 2013 - 2015

    • Presentation of lessons• Marking of exams

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  NRF/ Faculty of Natural and Agricultural Sciences

  • Mentorship Programme / Laboratory Assistant

    • 2012 - 2013

    • Organic chemistry synthesis• Chromatographic techniques• Chemistry analytical techniques • Laboratory reagent management

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  DST/NRF Centre for Excellence in Tree Health Biotechnology (CTHB)

  • Mentorship Programme / Laboratory Assistant

    • 2011 - 2012

    • Aseptic culturing techniques• Phenotypic screening (Vegetative compatibility group)• PCR and electrophoretic techniques• Gene sequencing

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  Cool Runnings

  • Barman and Waiter

    • 2010 - 2011

    • Stock and till management

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  Mr. FIXIT

  • Electricians Apprentice

    • 2007 - 2009

    • Electrical installations and maintenance• Project site foreman