Lize Meyer Email & Phone Number

Centurion, Gauteng, South Africa

Quality Management ConsultingPlant & Process DesignProcess ImprovementsISO Training & ImplementationGMP Training & Implementation Manufacturing UpscalingHygiene & Cleaning OptimizationLaboratory Testing Optimization Process ValidationCleaning ValidationPlant CommissioningSoftware Automation Implementation

Midrand

• Responsible for all quality processes:o Process improvementso RFT trendso Cost saving activitieso Process improvements from trending data • Owner of the METHOD OF MANUFACTURE o Feasibility studieso Equipment and process upscale processo Document approval processo Process adjustments• Technical lead of all Root Cause Analysis investigations • Quality Launch Coordinator:o Management of Quality related activitieso Manage feasibility studies o Quality representative for new launches• Validation responsibilities: o Owner of the sVMP and the Cleaning VMPo Validation of all first production batcheso Quality Validation dossiers for new production equipmento Assist new L’Oréal Plant (Kenya) with plant commissioning- Methods of manufacture- First validation batches- Evaluation of results and approval process- Cleaning validation• Industrial Hygienist:o Identification of all aspects in the plant requiring cleaning and or sanitizationo Implementation, validation, monitoring and optimization of systems and procedures o Troubleshooting and implementation of corrective actions o Manage Hygiene Committeeo Routine monitoring of the effectiveness of the hygiene program• Continuous Improvement Projects Leadero Annual improvement projectso Initiate project plans and lead the various teams to implementation• Manage and coordinate the stability programme for the laboratory• Act as stand in for Quality Manager• Establish with the Quality Manager goals and KPIs• Key contributor to development of elements of the Quality System• Monthly reporting of relevant KPIs to Plant Mancom and Corporate• Mancom meetings and Monthly industrial reviews with Corporate Management• Quality System auditor for internal; subcontractor and supplier audits• Quality audit team for ISO 9001:2008 and Corporate L’Oréal audit• Annual Management Reviews• Quality System documentation for areas of responsibility• Coaching and mentoring new members of the team

Johannesburg

KEY ACHIEVEMENTSLaboratory – Improved Overall Monthly Release Rate from 87% to > 98%Laboratory Analyst Cross-Training Improved Stock ProgramImproved Maintenance Program• Responsible for all quality processeso Timely, effective QA and QC support functions to manufacturing and packaging operationso Ensure that lead times agreed with production are followed o Check and authorize all analytical reports o Releasing / rejecting materials based on approved specificationso Ensure adherence to GLP and GHP is in practice by all laboratory staff o To manage QA laboratory budget control and staff o To assist with GLP, GMP and other related in-house training programs o To provide support to the QA and QC Managers in respect of day to day requirementso Assigning daily duties to each technician in accordance with the manufacturing and packaging plano To assist in the recruitment of new staff for the laboratory o To uphold safety regulations in the laboratoryo To co-ordinate monthly laboratory reports to QA Manager with respect to laboratory activities, budget / expenses, releases and rejectso To prepare new, and modify existing analytical methods in accordance with company policy and customer approval, where applicable o To ensure that all Validations are carried out in accordance with Validation requirements o To ensure self-inspection and supplier GMP and GLP audits are carried out timeously o To manage troubleshooting areas in the laboratory • Managing temperature and environmental monitoring throughout the whole factory• Managing Preventative Maintenance Programme on all laboratory equipment • Manages all calibrations and standardizations in the laboratory • Manages all client stability testing and data generated • Maintain and assist in keeping SOP’s updated • Manages maintenance and control of hazardous waste

Midrand

KEY ACHIEVEMENTSImplement Validation Program, sVMP, Cleaning VMP & Process ProtocolsImplement In-House Validation Meetings to ensure alignment of all Departments for all Launches• Responsible for all Quality Validation Processeso Drawing up and updating Site Validation Master Plan, Client specific Validation Master Plans and Protocols and Protocols for identified Validationso Carry out and manage actual Validation testing as per Protocol o Assisting Production team in choosing correct manufacturing vessel and filling lines required for each validationo Ensuring raw materials identification and testing was done according to client specificationso Ensuring manufacturing vessels and filling lines are cleaned and sanitized correctlyo Supervising validation with cliento Ensuring necessary changes made to manufacturing procedure during validation has been implemented through a Change Control Procedure and that client receives new manufacturing document for approvalo Troubleshooting formulation queries and problems with R&D and implementing the necessary changes through a Change Control Procedureo Writing up Validation Reports• Co-Ordinate meetings with relevant Departments and clients involved with Validation so that the process runs smoothly• Implement and improve systems where necessary • Supervise laboratory personnel (Raw Material and Chemistry testing) and Manufacturing Personnel (Dispensary and Compounding Operators)Client Validations done include:- Alberto Culver - Justine Avon- Woolworths- Avroy Schlain- Unilever- Johnson & Johnson- Procter & Gamble• Overseeing and handling Client and Customer Complaints• Internal Audits (Manufacturing and Production, Dispensary and Laboratory)Co-Ordinate all Process and Plant Validation functionsManaged all equipment validation in the Plant Process and formulation improvementsTroubleshooting Manufacturing batchesLaunch and new client validation in Production

Midrand

KEY ACHIEVEMENTSImproved Raw Material Testing Release Rate > 50%Improved Standard Operating Procedure ProgramImproved In-House Equipment Maintenance Program• Responsible for all Quality testing includingo Identification and analysis of raw materials for the cosmetics industry o Assisting Laboratory Supervisor in coordinating laboratory testing o Drawing up Standard Operating Procedureso Equipment calibrations and general maintenance

Midrand

KEY ACHIEVEMENTSImproved Raw Material Testing Release Rate > 60%Improved In-House Equipment Maintenance Program• Responsible for all Quality testing includingo Identification and analysis of raw materials for the infant nutrition industryo Chemical Analysis of finished baby nutritional products o Equipment calibrations and general maintenance

Boksburg

KEY ACHIEVEMENTSImproved Analysis Testing Release Rate > 30%Improved In-House Equipment Maintenance ProgramImproved Standard & Stock Control Program• Responsible for all Quality testing includingo Chemical Analysis of pesticides, fungicides and fertilizers o Analysis of raw materials for the cosmetics industry o Chemical Analysis of foods and related products o Equipment calibrations and general maintenanceo Standards Controller o Stock Controller

Kempton Park

KEY ACHIEVEMENTSTuberculosis Testing Team LeaderImproved Monthly Project Release Rate from 78% to > 95%Improved In-House Equipment Maintenance ProgramImproved Degradation Products Stability, Storage & Testing MethodsMethod Transfer to Quality Control Lab for Tuberculosis Batch Releasing• Responsible for all Quality processes and testing includingo Physical testing of pharmaceutical and Tuberculosis dosage formo Stability testing of pharmaceutical and Tuberculosis dosage formso Method Transfer of Tuberculosis analytical testing methods to Rolab Quality Control Laboratoryo Process Validations on newly formulated Tuberculosis dosage form• Tuberculosis Team LeaderEnsuring stability schedule is maintained Project co-ordination of stability samples Tuberculosis Standard Controller Troubleshooting on existing analytical methodsTroubleshooting team member problems experienced during stability testing • Stock Controller • Equipment calibrations and general maintenance

Pretoria

KEY ACHIEVEMENTSImproved In-House Equipment Maintenance ProgramImproved Stability Testing ProgramMethod Development of dual active ingredients in drug dosage forms• Responsible for all Quality testing includingo Assisted formulation pharmacist in manufacturing trial dosage forms for stability studieso Troubleshooting on formulations to improve quality and shelf lifeo Physical testing on pharmaceutical stability dosage forms as well as in process trial dosage formso Raw material analysis and identificationo Stability testing on pharmaceutical dosage forms• Analytical Method Validations on various newly developed methods as well as existing methods • Analytical Method Development for various new clients• Standards Controller• Stock Controller• Equipment calibrations and general maintenance