Essential knowledge: The candidate must be able to demonstrate essential knowledge required to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role This includes knowledge of: Auditing arrangements, roles and responsibilities as they relate to own work responsibilities, which may include understanding of the purpose and process for internal and external audit processes Basic concepts of quality assurance including quality specifications, operating parameters, validation procedures and control methods including understanding of related documentation including Standard Operating procedures Clothing and footwear requirements for working in and/or moving between work areas Control methods and procedures used in the work area to maintain GMP including: identifying variances to the manufacturing process understanding of the methods used to monitor process control understanding of the purpose of control, the consequence if not controlled; and the method of control where relevant It may also include: corrected use and supply of quality manufacturing aids purpose and requirements of validation procedures purpose of equipment calibration understanding of methods used to monitor process control Current technical and process knowledge required to monitor GMP and participate in investigating GMP non-compliance within level of responsibility, including: conditions under which types of contamination are likely to occur related control methods and validation procedures and responsibilities understanding of common micro-biological, physical and chemical contaminants Documentation systems and procedures, including record keeping to meet both organisation and legal requirements, procedures for developing and/or reviewing workplace procedures and document control systems used in the workplace GMP arrangements in the workplace, including awareness of relevant GMP codes of practice and related workplace policies and procedures to implement these responsibilities GMP responsibilities and requirements relating to the work area Housekeeping requirements and responsibilities relating to own work (where relevant this includes use and storage of housekeeping/cleaning equipment) continued ... |