Experience

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  Kiara Health

  • Johannesburg

  • Quality Systems/Compliance Officer

    • Aug 2020 - Present
    • Johannesburg

• 

  Sandoz

  • Switzerland
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Quality Compliance Officer

    • May 2009 - Aug 2020

    Assist the Head of Quality Assurance in ensuring Total Quality Management.Generation and evaluation of Annual Product Quality Reviews (APQR’s) for locally manufactured generic products and evaluation of third party manufactured APQR’s. Statistical evaluation ie. Capability Index (Cpk) utilizing Minotab software.Perform GMP audits and drive implementation of corrective actions through project management (AQWA auditing system).Co-ordinate and control company Standard Operating Procedures (SOP’s),ensuring the company QA systems are in compliance with global company and legal requirements.Site owner of an electronic document management system (SDMS).Training on the system is conducted and control of daily workflow and troubleshooting is performed.Generation of Technical Agreements for API suppliers and Third Party Manufacturers.Deviation and CAPA management (Corrective and Preventative Actions) utilizing Trackwise.Validation (Cleaning and Product).Risk Management.Change Control.Customer Complaints.SAP

  • Senior Laboratory Analyst

    • Oct 2005 - May 2009

    Release,validation and stability analysis of locally manufactured bulk generic products,imported third party manufactured products as well as raw materials utilizing in-house testing monographs as well as the European,British and United States Pharmacopoeial methods.Instrument Calibration.Reference standard ordering and monitoring.Instrumentation:High Performance Liquid Chromatography (HPLC),Gas Chromatography (GC),Infrared Spectroscopy (FTIR),UV-Vis Spectroscopy,Malvern Particle Size Analyser,Melting Point Apparatus,Karl Fisher-water determination,Polarimeter,Refractometer,Autotitrator,Disintegration Bath,Dissolution,Hardness,Viscometer.

• 

  Modderfontein Laboratory Services

  • Laboratory Analyst

    • Apr 2005 - Sep 2005

    Contract position replacement for person on maternity leave.

• 

  Bioforce South Africa

  • Midrand

  • QA Head

    • Aug 2004 - Mar 2005
    • Midrand

    Running of a small testing QC laboratory with a Microbiological section.Supervision of laboratory and production staff.Ensuring GLP,safety and GMP compliance within the facility.Running of a stability program.Documentation control.Standard opearting procedures within the whole facility.Analytical method development for testing of imported products.Instrument calibration and validation.Liaising with overseas management.Supplier and contract laboratory auditing.Product flow within the warehouse and stock transfer of goods.Control of Artwork.

• 

  Sandoz South Africa

  • Spartan,Gauteng.

  • Laboratory Analyst

    • Aug 2000 - Jul 2004
    • Spartan,Gauteng.

    Release,validation and stability analysis of locally manufactured bulk generic products,imported third party manufactured products as well as raw materials utilizing in-house testing monographs as well as the European,British and United States Pharmacopoeial methods. Instrument Calibration. Reference standard ordering and monitoring. Instrumentation: High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Infrared Spectroscopy (FTIR), UV-Vis Spectroscopy, Malvern Particle Size Analyser, Melting Point Apparatus, Karl Fisher-water determination, Polarimeter, Refractometer, Autotitrator, Disintegration Bath, Dissolution, Hardness, Viscometer.

• 

  A.E.C.I

  • Modderfontein,Gauteng

  • Senior Laboratory Analyst

    • Oct 1996 - Jul 2000
    • Modderfontein,Gauteng

    Analysis of raw materials and intermediate products for a variety of production plants producing explosives; African Explosives Limited,Kynoch (Fertilizer) and Kynochem (Chemicals).Organization and implementation of non-routine as well as project management.Method adaptation and development.Experience:Titrimetric analysis,Spectrophotometric analyses (UV-VIS),Viscosity (Cone and plate,Brookfield synchro electric),Gravimetric analysis,Density (Anton Paar),Moisture determination (AF5 and Karl Fischer),pH determinations,Turbidity,Distillation (Kjeltec), Instron tensile testing,Specific surface area,Bomb Calorimetry,Aqua Doc(Total Dissolved Organic Carbon) andPulse Polarography.Instrumentation:X-Ray Fluorescence spectroscopy,I.C.P. –A.E.S,Atomic Absorption Spectroscopy (A.A.S),

• 

  Coca-Cola

  • Bedfordview,Johannesburg

  • Syrup Room Controller

    • Nov 1995 - Sep 1996
    • Bedfordview,Johannesburg

    Syrup manufacture for production using an Alfa Laval sugar dissolving plant.Brix readings,final volumes and amount of simple syrups needed per batch.Addition of concentrate flavourants and preservatives.Calibration of tanks.Sanitization procedures.Daily reports for works and production managers.Liaise with and supervision of production personnel. Postmix and Minipom production.

• 

  The Coca-Cola Company

  • Bedfordview,Johannesburg

  • Laboratory Analyst-In service training

    • Jan 1994 - Jul 1994
    • Bedfordview,Johannesburg

    Brix (sugar) determination of fresh syrups and finished products using hydrometers and refractometers.Taste testing,fill heights,closure torgues,washer temperatures and Chlorine determinations.

• 

  Chemical Services (Pty) Limited

  • Chloorkop,Johannesburg

  • Laboratory Analyst-In service training

    • Dec 1991 - Jun 1992
    • Chloorkop,Johannesburg

    The analysis of raw materials and finished products from the industrial,water treatment,metal,food sciences and fire fighting divisions. Analysis included pH,specific gravity,moisture and viscosity determinations. Wet chemistry and standardizations were performed.