Experience

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  Kiara Health

  • South Africa
  • Pharmaceutical Manufacturing
  • 100 - 200 Employee

  • Analytical method validation officer

    • Aug 2020 - Present

    ➢To perform method development for the finished products to obtain optimum chromatography and efficient analytical methods.➢To source the standards, reagents and HPLC columns required for the method development and validation testing.➢To compile raw data and method development reports.➢ Perform analytical method validations for FDF and raw materials in accordance with MCC and SAPHRA requirements.➢To compile validation data, evaluate and interpret results obtained.➢To compile method validation report for submission to regulatory.➢To review method validation protocols and reports. ➢ To provide scientific / analytical / technical support to the QC unit to allow for efficient and reliable QC testing by solving laboratory problems, investigations and deviations.➢ To execute the planned upgrading of raw material and finished product analytical methods used in Kiara Health (Pty) Ltd.➢ To Create & Validate Excel Template’s for dissolution calculation.➢ Preparation and review of SOPs for QC operations.➢ Report deviations and issues in time limits. Investigate and find the root cause and create appropriate CAPAs for the deviations.➢ Assist in compilation of training material and training of QC analysts to improve efficiency and reduce errors.➢ Handling & Monitoring of HPLC column requirements.➢ Train other analysts in method validation activities & ensure data integrity and cGMP is followed at all times.

  • Senior method validation analyst

    • Jul 2015 - Present

    ➢To perform method development for the finished products to obtain optimum chromatography and efficient analytical methods.➢To source the standards, reagents and HPLC columns required for the method development and validation testing.➢To compile raw data and method development reports.➢ Perform analytical method validations for FDF and raw materials in accordance with MCC and SAPHRA requirements.➢To compile validation data, evaluate and interpret results obtained.➢To compile method validation report for submission to regulatory.➢To review method validation protocols and reports. ➢ To provide scientific / analytical / technical support to the QC unit to allow for efficient and reliable QC testing by solving laboratory problems, investigations and deviations.➢ To execute the planned upgrading of raw material and finished product analytical methods used in Kiara Health (Pty) Ltd.➢ To Create & Validate Excel Template’s for dissolution calculation.➢ Preparation and review of SOPs for QC operations.➢ Report deviations and issues in time limits. Investigate and find the root cause and create appropriate CAPAs for the deviations.➢ Assist in compilation of training material and training of QC analysts to improve efficiency and reduce errors.➢ Handling & Monitoring of HPLC column requirements.➢ Train other analysts in method validation activities & ensure data integrity and cGMP is followed at all times.

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  Pharmaspec Consulting Laboratries

  • City of Johannesburg, Gauteng, South Africa

  • Senior Quality Control Analyst

    • Feb 2015 - Jun 2015
    • City of Johannesburg, Gauteng, South Africa

    • Conducting qualitative and quantitative analysis of pharmaceutical raw material and finished products such as tablets, capsules ,syrups, ointments , injections using HPLC,UPLC,GC,UV/Vis, AAS, Titrimetry as per company methods and in accordance to SOP• Performing physical tests such as friability, dissolution, disintegration, dispersion time, hardness, etc for tablets and capsules.• Operation and maintenance of UPLC and HPLC as per schedule.• Performing stability tests of samples.Page 3 of 4• Performing method validation of pharmaceutical material.

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  SUN PHARMA

  • Vadodara, Gujarat, India

  • Research Officer in pharmacokinetics department

    • May 2008 - Feb 2014
    • Vadodara, Gujarat, India

    • Operating of UPLC MS/MS API – 5000 and HPLC MS/MS API - 4000• Method Validation and Development of complex molecules in human plasma and pilot and pivotal studies as per USFDA, ICH, ANVISA guidelines.• Responsibilities to implement and maintain GLP in Bio-analytical Laboratory• Perform other physical and analytical testing using instruments such as Auto-Titrator, Density Meter, Refractometer, Spectrophotometer as required.• Preparation of analytical test procedures and tentative analytical test procedures for studies and method validation• Preparation, review and submission of Bio-analytical reports• Calibration and maintenance of Instruments-HPLC, Analytical balance, Micropipette, pH meter• Responsible for operation ,calibration and maintenance of data logger system• Temperature monitoring of deep freezers, cold rooms and refrigerators. Temperature and humidity monitoring of LC/MS/MS rooms and processing labs.