Knowledge of: purpose and basic principles of the liquid manufacturing process, including the characteristics and basic function of raw materials used, and method and sequence of addition required to achieve required mix characteristics, and where required, the characteristics of solutions, suspensions and emulsions basic understanding of specific gravity and bulk density as appropriate for ingredients used basic operating principles of liquid manufacturing equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, the purpose and location of sensors and related feedback instrumentation, and awareness of calibration schedules for scales and related weighing/measuring equipment services required and action to take if services are not available stages and changes which occur during liquid manufacturing quality characteristics and legal requirements to be achieved by the liquid manufacturing process the flow of the liquid manufacturing process and the effect of outputs on downstream pharmaceutical processes operating requirements and parameters and corrective action required where operation is outside specified operating parameters typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems methods used to monitor the liquid manufacturing process, such as inspecting, measuring and testing as required by the process inspection or test points (control points) in the liquid manufacturing process and the related procedures and recording requirements, including monitoring: flow rates materials addition sequence times/temperatures and agitator speeds required characteristics of manufactured liquid GMP requirements associated with the liquid manufacturing process and related control measures common causes of variation and corrective action required product/process changeover procedures and responsibilities occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment relevant to the work process end-of-batch procedures, including procedures for calculating yield, materials reconciliation and action required if yield/reconciliation is not within prescribed limits, and product labelling responsibilities and procedures requirements of different shutdowns as appropriate to the liquid manufacturing process and workplace production requirements, including emergency and routine shutdowns and procedures to follow in the event of a power outage line clearance, cleaning and sanitation procedures isolation, lock out and tag out procedures and responsibilities procedures and responsibility for reporting production and performance information environmental issues and controls relevant to the liquid manufacturing process, including waste collection and handling procedures related to the process basic operating principles of process control, where relevant, including the relationship between control panels and systems and the physical equipment sampling and testing associated with process monitoring and control where relevant routine maintenance procedures where relevant |