Flora Makhura

Flora makhura

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location of Flora MakhuraCity of Johannesburg, Gauteng, South Africa
Followers of Flora Makhura799 followers
  • Timeline

  • About me

    Validation Officer Aspen SA Ops

  • Education

    • Vaal university of technology

      2017 - 2019
      Btech biotechnology
    • Vaal university of technology

      2012 - 2013
      National diploma in biotechnology biotechnology\microbiology\food technology national diploma

      Activities and Societies: GTI Choir member from VUT.

    • Alison

      -
      Qms quality assurance
    • O

      2012 - 2013
      National diploma in biotechnology biotechnology

      A member of Choir * Vaal University of Technology*

  • Experience

    • Newport juices

      Mar 2014 - Mar 2015
      Trainee qc lab technician

      Duties under Microbiology:• Preparations of solution , micro media, micro testing of incoming water sample, swab analysis which include ATP swabs, hands swab and normal swab• Micro testing of packaging, i.e, caps and bottles• Micro testing of shelf- life samples• Organoleptic sample of retention samples• E.coli testing and micro testing on after pasteurized sampleDuties under Chemistry:• Mixing and on-line sample testing including the following;BrixTitratable AciditypHTemperature checksTaste• Calibration and monitoring of lab equipment e.g. the brix meter( refractometer), incubators, scales and fridges• CIP chemical concentration using test kidDuties under Quality Assurance:• Factory Inspection which include the followings:Glass and Plastic checklistForeign object checklistGMP checklistOther duties:• Monitoring of Ozone readings• Collection of Raw Materials and Aseptic sample for biological testing and chemical testing• Customer complain treaceability Show less

    • Kingsley beverage

      Jun 2015 - Feb 2018
      Qc lab technician

      Description of duties• Chemical and Microbiological testing of the product and raw materials• Calibration and control of lab instrument• Basic maintenance of lab equipment• Monthly report on the Nonconformance and corrective action• Housekeeping in the lab• Product release and Carbonation testing• Sensory evaluation of products• Taking and handling of samples• Seam checking• Water testing/ water treatment

    • Adcock ingram

      Mar 2018 - Mar 2019
      Validation officer

      Validation and qualification(IQ, OQ, PQ) requirements for facilities, utilities and equipment ensuring cGMP compliancyEnsuring that the all equipments are validated and qualified to meet cGMP and GLPDeveloping and determining validation criteria for new equipment and or facility upgradeExecution of cleaning validation protocolsDrafting and Executing Sanitizer efficacy verification protocol in Microbiology labQualification of lab equipments, eg analytical balances and laboratory glassware washerCompilation and updating of validation documentsPerforming action required by quality management system including change control, deviation, non-conformance and risk assessmentCoordination of the validation protocols/reports for approvalTemperature mapping Show less

    • Adcock ingram critical care (pty) ltd.

      Nov 2020 - Feb 2021
      Validation coordinator

      • Performing equipment Qualification on existing and new equip per SOP/PIC/SAHPRA requirement• Preparation and execution of validation protocol• Involved in a continues improvement • Performing Cleaning Validation studies/hold time studies• Working in compliance with cGMP• Periodic reviews on existing equipment• Quality Steam testing

    • Msd south africa

      Mar 2021 - Sept 2021
      Validation specialist

      • Back-up sub-system owner for QMS Chapter 13 - Cleaning Validation and Chapter 17 -Equipment Qualification.• Contributes to authoring, updating and execution of the Site Validation Master Plan (VMP)• Planning and execution of Equipment Qualification and Cleaning Validation activities in collaboration with the equipment/process owners, supporting contractors and vendors• Authoring, updating and/or reviewing standard operating procedures for Equipment Qualification and Cleaning Validation• Authoring and/review of Equipment Qualification & Cleaning Validation protocols and reports• Assessing equipment, utility and/or facility changes for Qualification and Cleaning Validation impact• Contributing to the execution of the periodic review program for Equipment Qualification and Cleaning Validation to ensure qualification/validation status remains valid• Participating in internal collaborations through Equipment Qualification and Cleaning Validation Communities of Practices (CoP)• Developing change controls in collaboration with IPT and quality teams, as required• Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs) product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact (DPOC) Show less

    • Aspen pharma group

      May 2022 - now
      Validation officer

      *Performing validation exercises in compliance with GMP standards and validation schedules.*Maintaining compliant status of equipment and processes (systems, cleaning)*Performing the relevant operational qualification protocols as per SOP to ensure new equipment/utilities/ packaging function as per intended use.*Performing the relevant performance qualification protocols as per SOP to ensure new equipment/utilities/ packaging function as intended over time and within limits.*Investigating and reporting OOE results and perform re-tests.*Participating in change control assessments to ensure compliant status of affected equipment is notcompromised.*Conducting routine inspections of equipment and utilities to identify any deficiencies and ensurequality standards are being adhered to.*Ensuring documents and procedures to operate and maintain equipment are in place.*Assessing and recommending re-qualification of equipment and utilities as appropriate as per Protocol.*Preparing and performing re-qualification of equipment and utilities as per SOP.*Compiling, maintaining and updating validation documentation as per SOP and QMS.*Performing Cleaning Validation studies, Protocol and execution .*Generating validation reports on a weekly/ monthly basis. Show less

  • Licenses & Certifications

    • National diploma certificate in biotechnology

      Sept 2015
    • Baccalaureus technologiae

      Vaal university of technology
      Sept 2019
    • Six sigma black belt certification – level iii

      Training leadership consulting
      Sept 2024