Knowledge of: the role of GMP in preventing contamination, its relationship to legal requirements of pharmaceutical manufacturers and potential implications of non-compliance GMP arrangements in the workplace, including relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities the relationship between GMP and the quality system, personnel responsible for designing and managing GMP, personal role to maintain GMP, and the role of internal and external auditors as appropriate procedures followed to investigate contamination events and performance improvement processes personal clothing and footwear requirements for working in and/or moving between work areas personal clothing use, storage and disposal requirements awareness of common micro-biological, physical and chemical contaminants relevant to the work process, including the types of contamination likely to occur, such as cross-contamination, the conditions under which they occur, possible consequences and control methods to prevent occurrence basic concepts of quality assurance, including quality specifications, operating parameters, validation procedures and control methods, and related documentation, including standard operating procedures (SOPs) and/or batch instructions control methods and procedures used in the work area to maintain GMP, including an understanding of the purpose of control, the consequence if not controlled and the method of control where relevant, as well as an understanding of the methods used to monitor process control basic understanding of the properties, handling and storage requirements of raw materials, packaging components and final product handled and used standards for materials, equipment and utensils used in the work area procedures for responding to out-of-specification or unacceptable performance/outcomes purpose of keeping records and the recording requirements of GMP, including product and materials traceability procedures housekeeping requirements and responsibilities relating to own work, and use and storage of housekeeping/cleaning equipment where relevant waste collection, recycling and handling procedures relevant to own work responsibilities responsibilities for reporting and recording quality information |