Job PurposeExecutes production activities by operating machinery and equipment under the supervision of the Production Supervisors, Pharmacists and Pharmacist Assistants. Implements the production plan and targets according to prescribed BMRs, SOPS and cGMP, while maintaining the highest level of Quality, Safety and Productivity.Key AccountabilitiesOperations and ProductivityResponsible for timeous line start up (minimize down time, increase ouput)Inspection and certification of clean equipment and the completion of the relevant production documentation in accordance with the relevant SOP’S (logbooks, checklist sheet, performance measures)Strip down and cleaning of equipment according to production documentation and SOP’sAssembly and operation of equipment according to production documentation and SOP’sStorage preparations of cleaning and sanitizing solutions according to SOP’sMaintaining stock levels of consumable items thereby ensuring availability for the use in productionEnsuring availability of cleaning agentsCleaning of wall panels, floors, windows, auxiliary equipment as per relevant SOPConduct start up checklists and regular I.P.C check according to SOP’s and as specified in the production documentationSetting up machine including change overEnsure adjustments settings on machine to ensure quality product produced efficientlyAll work/operation must be carried out as per condition stipulated in the OHS ACT (working safely)Shift handover – primary operators responsibility of equipment and room per shiftCarry out work related instructions that are issued by the Supervisor Pharmacist according to the relevant documentation e.g BMR/BPR, SOP’s protocols or QA approved documentationReport deviations (Quality and work related) immediately to your supervisor/IPC inspector and shift pharmacistReports breakdowns immediately to Supervisor and pharmacistEnsure breakdowns are timeously attended to by liaising with the fitter/supervisorParticipate in production Optimization (minimise waste, quick change over, identification and resolve delays/ constraints before they occur, contribute to downtime minimization ensure that all material/documents tools and equipment are availableParticipate in training and development programmes and or assist in training of peer trainees (new staff)Is responsible for carrying out line set up process and must ensure accuracy and correctness of all material issued to a job as per BMR/BPR and Syspro documentEnsure functional integrity and safety of machine before use and report any abnormality or defect immediately to your Supervisor/PharmacistReport component that are of in consistent quality and defects immediately to supervisor, IPC inspector and or shift pharmacistTimeous and correct filing in of information on relevant documentationOperation of machine as per good engineering practicesContinuous monitoring of quality of products to ensure specification as per Quality Standards are met, and reporting any deviations immediatelyTo be competent in operational, cleaning of equipment as per SOPComplete practical assessment and to be found competentConduct shift handover between operators (to arrive 10 minutes before start of shift on line to communicate with operator)DocumentationTimeous and correct filing in information on relevant documentation document e.g BMR/BPR Logbooks etc. SOP’s and protocols or QA approved document log books verification line diariesAssist in the drawing up of relevant documentation e.g BMR/BPR, SOP’s Protocols, as well as recommendation proposals to existing documentationAble to write operating/cleaning procedures for equipment/processesMaintenanceReport to Supervisor if maintenance/equipment checks are conducted according to guidelines specified in the relevant SOP’sReport breakdowns immediately as per SOPAssist engineering with breakdown when requiredAttending to minor breakdownsAdjustments to machineEnsure that breakdowns and maintenance are correctly and timeously recorded in the relevant logbooksGMP and SafetyMaintenance and adherence to cGMP/PICS and safety standards in the departmentActive participation and liaisons in internal and external quality auditsEnsure competency on all relevant SOP’sOperational PlanningPlan daily activities in order to meet the agreed daily production targets at respective areasMeeting required ORE scoresCommunicationActively participate in regular team meeting and shift handoversProblem solvingAble to detect and analyse deviations in start-up and in process checks and respondResponse will include active involvement with Pharmacist/Supervisor and Engineering to correct deviationsAble to detect and analyse deviations in product during the processing and respond accordingly. Response will include active involvement with the Department head and other relevant departmentAble to problem solve, trouble shoot and resolve machine problemsAccountabilityRespond solely for the setup and operation of equipment and processes according to validated parametersDeviation from these parameters will have a negative impact on the product and equipmentFor achieving the daily output target and making alternate plans to achieve the target in the events of delays/errorsMonitoring and maintaining overall resource efficiency at acceptable levelsAccountable for equipment used during the shift at your allocated workstation, line/cubicleSkills & KnowledgeEducational qualifications:Matric/ Grade 12 (with Mathematics & English)Added Advantage: National Diploma in Mechanical or Electrical Engineering or equivalentRelevant experience:1-3 years relevant experience in a Pharmaceutical Industry