Andile Mbele

Experience

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  Tshwane University of Technology

  Jan 2008 - May 2008

  Laboratory Assistant

  Conduct lab practical for studentsHelp carrying out test resultsCompleted experiential learning (I)Assist chemistry research team in research workInstrumentation skills:Chromatographic techniques (Column chromatography, TLC, HPLC and GC)Atomic and molecular absorption (AA, FTIR, ICP MS and ICP OES

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  Sun Ace South Africa Pty

  Jun 2008 - Mar 2009

  Analytical Chemist

  Reagent PreparationStandardization of volumetric solutions Test ApparatusPhysical testingProduct Status NotificationLaboratory equipment maintenanceProcess monitoringProduct developmentFinish product testingWorking environment and Safety managementRaw material and finish product testingInstrumentation skills:BrabenderCongo red indicator instrumentEnergy dispersive Xray

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  Betabs Pharmaceuticals

  Sept 2010 - Aug 2012

  QC Analyst

  Analysis of raw material as per SOPAnalysis of finished products as per SOPIn process sample analysis as per SOPStability AnalysisIdentification TechniquesDisintegration time analysis and physicals Assay AnalysisLoss on dryness analysis (LOD)HPLCGCDissolution Testing Identification of Samples Samples Analysis using AA Sample analysis using Auto titration Dimension Analysis of Capsules UV/VIS SpectroscopyMelting PointStability TestAADensity measurements on samples RI(refractive index) measurements on samplesFTIR spectrum(infra red) measurement on samplesStandardization of volumetric solutionsWater moisture using Karl FischerChecking viscosity using viscometerPolarity measurement using polarimeterGLPReporting and documentationInstrumentation skills:Chromatographic techniques (UPLC, TLC and GC)Atomic and molecular absorption (AA, FTIR, UV/VIS) PolarimeterDissolution bathRefractrometerViscometerDistillationParticle size analyser TitroprocessorKarl Fischer water analyserMelting and boiling point instrument Show less

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  Bioforce SA (Pty) Ltd

  Apr 2013 - Aug 2013

  Laboratory Supervisor

  Maintain the whole QC departmentProduction line opening and closingRemoving of samples from pastell systemCreating order formsTrainingCustomer complaintsHygiene, pest control and environmental controlCalibration of lab equipmentDrafting and updating of SOP’sPreventative maintenanceSort out quality issues with suppliers and in-houseMonthly temperature monitoring graphs for all areasWriting-off expired goods in warehouse- give copies to stock controllerPurified water- maintain the system, monthly disinfection and weekly chemical and microbiological testingConducting internal inspection- reporting and filing Supplier auditingDaily temperature recording and monitoring of the stability chamberApprovals and rejectionsBatch packing records Show less

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  Nkunzi Pharmaceuticals

  Aug 2013 - Oct 2013

  Laboratory Analyst

  Industry PharmaceuticalDutiesAnalysis of raw material Analysis of finished products In process core sample analysisStability AnalysisIdentification TechniquesAssay AnalysisHPLCGCDissolution Testing Identification of Samples using NIR and wet chemistrySample analysis using Auto titration UV/VIS SpectroscopyWater moisture using Karl FischerGLPReporting Instrumentation skills:Chromatographic techniques (HPLC, TLC and GC)Atomic and molecular absorption ( NIR, UV/VIS) PolarimeterDissolution bathDistillationTitroprocessorKarl Fischer water analyser Show less

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  Adcock Ingram

  Oct 2013 - Dec 2015

  Analysis of raw material Analysis of finished products Identification TechniquesAssay AnalysisHPLCGCDissolution Testing Samples Analysis using AA Sample analysis using Auto titration UV/VIS SpectroscopyMelting PointDensity measurements on samples Refractive index measurements on samplesFTIR spectrum measurement on samplesStandardization of volumetric solutionsWater moisture using Karl FischerChecking viscosity using viscometerPolarity measurement using polarimeterGLPReporting and documentationInstrumentation skills:Chromatographic techniques (UPLC, TLC and GC)Atomic and molecular absorption (AA, FTIR, UV/VIS) PolarimeterDissolution bathRefractrometerViscometerDistillationParticle size analyserTitroprocessorKarl Fischer water analyserMelting and boiling point instrument Show less

  • Laboratory Analyst

    Jan 2014 - Dec 2015

  • Validation Specialist

    Oct 2013 - Dec 2013
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  Adcock Ingram Critical Care (Pty) Ltd.

  Jan 2016 - Jun 2017

  Metrologist

  1. Prepare and maintain calibration, qualification and preventative maintenance schedule for all analytical equipment2. Prepare protocols and execute the same for validation of analytical equipment3. Generate SOP’s where relevant for analytical equipment4. Perform calibration verification and qualifications of Instruments5. Maintain reference equipment in a calibrated state6. Train analysts on the SOP’s for new instruments7. Compliance to GMP/GLP/SHE

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  Adcock Ingram

  Jul 2017 - Apr 2021

  Validation Coordinator

  Preparation of Validation protocols for process and utilities.Performing and sampling for validation / qualification studiesPreparation / review and approval of URS / FAT / SAT / DQ / IQ / OQ and PQ protocols and reportsPreparation / review and approval of SOPs of Validation DepartmentParticipation in the internal and external auditsImplementation of validation / qualification policiesQualification of facility, HVAC, equipment and utilities.Execution of Validation Project ManagementPerform periodic validation / qualification activities as per schedules.Document control of qualification activitiesControl and update of all monitoring and measuring devices used for validation / qualification studiesCompliance to regulatory requirements with respect to equipment qualifications / facility qualifications / utility qualifications.Ensure compliance to cGMP and Site Quality Management Systems. Ensure all changes are handled in accordance with the relevant change control procedure. Ensure that all deviations are reported and handled in accordance with the deviation procedure. Participate in Quality Risk AssessmentsProvide data for Product Quality Reviews.Preparation of Cleaning Validation activities and execution of Cleaning Validation Studies.Performance of Temperature and Humidity Mapping studies on Storage Areas. Show less

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  Aspen Pharma Group

  May 2021 - Nov 2021

  Validation Officer

  Planning and Operational SupportAct as a technical/ subject matter resourceFacilitate implementation of current processesIdentify gaps in current policies and proceduresProvide input into changes or improvements to processes, tools and techniques ValidationPerform validation exercises in compliance with GMP standards and validation schedulesMaintain compliant status of equipment and processes QualificationPerform the relevant operational qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as per intended usePerform the relevant performance qualification protocols as per SOP to ensure new equipment/ utilities/ packaging function as intended over time and within limitsInvestigate and report OOE results, and perform re-testsParticipate in change control assessments to ensure compliant status of affected equipment is not compromisedConduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered toEnsure documents and procedures to operate and maintain equipment are in place RequalificationAssess and recommend re-qualification of equipment and utilities as appropriate as per ProtocolPrepare and perform re-qualification of equipment and utilities as per SOP Reporting and Record-KeepingCompile, maintain and update validation documentation as per SOP and QMSGenerate validation reports on a weekly/ monthly basis Show less

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  Aspen South African Operations

  Nov 2021 - now

  Duties & Responsibilities include: ● To facilitate the validation of production and lab equipment and utilities on site and to assist and supervise the Validation Officer in the validation of associated equipment and processes.Operational Activities● Plan, lead, allocate and manage based input from manager and departmental activities, resources and tasks in accordance with agreed budgets, service/delivery targets and daily/weekly/monthly plans.● Maintain appropriate systems for operational management and measurement.● Maintain the Validation Plans and Validation SOP’s to ensure continued compliance at all times.● Manage the completion of activities associated with the Validation Plans.● Compile and execute the relevant Qualification protocols as per SOP.● Control of Validation Documentation as per SOP.● Evaluate the results from executed validation protocols.● Generate validation reports.● Adhere to change control associated with utilities and equipment.● Assist with Change Controls.● Assist with the completion of activities associated with the Validation Plans.● Adhere to Validation practices, policies and procedures.● Adhere to Good Engineering Practices.● Adhere to the Quality Management Systems for Validation documentation (includingnon-standard workloads, new ad hoc equipment and production deadline requirements).● Assist with review of re-validation Plan.● Prepare and execute re-qualification as per SOP.● Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol.● Always maintain and audit compliant state within the validation department.● Manage departmental financial, SHE, HR and GMP responsibilities and activities.● Ensure all test equipment is maintained and calibrated as per approved schedule and traceable. Show less

  • Validation Manager

    Jan 2024 - now

  • Validation Team Leader

    Nov 2021 - Jan 2024