Knowledge of: purpose and basic principles of the encapsulation process basic operating principles of equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, and the purpose and location of sensors and related feedback instrumentation services required and action to take if services are not available types of raw materials used in the encapsulation process and related handling/segregation requirements, such as handling hazardous goods stages and changes which occur during encapsulation quality characteristics and legal requirements to be achieved by the encapsulation process the flow of the encapsulation 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 encapsulation process, such as inspecting, measuring and testing as required by the process inspection or test points (control points) in the encapsulation process and the related procedures and recording requirements GMP requirements associated with the encapsulation 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 encapsulation 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 encapsulation 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 |