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 role of effective communication and consultation processes workplace training and development system and responsibilities role of quality assurance and related system components and activities in GMP 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 current technical and process knowledge required to monitor GMP and participate in investigating GMP non-compliance within level of responsibility, including common microbiological, physical and chemical contaminants, conditions under which types of contamination, e.g. cross-contamination, are likely to occur, related control methods and validation procedures and responsibilities control methods and procedures used in the work area to maintain GMP, including the purpose of control, the consequences if not controlled and the method of control where relevant methods used to monitor process control, purpose and requirements of validation procedures and purpose of equipment calibration recall and traceability procedures relevant to work area line clearance procedures and responsibilities properties, handling and storage requirements of raw materials, packaging components and final product handled and used in the work area standards for materials, equipment and utensils used in the work area procedures for responding to out-of-specification or unacceptable performance/outcomes, including procedures for identifying and isolating or quarantining materials or product of unacceptable quality within level of responsibility documentation system and procedures, including record keeping to meet both company and legal requirements, procedures for developing and/or reviewing workplace procedures and document control systems used in the workplace and responsibilities for reporting and recording information housekeeping requirements and responsibilities relating to own work, and where relevant, use and storage of housekeeping/cleaning equipment waste collection, recycling, handling and disposal, including handling/disposal requirements for different types of waste, such as hazardous waste where relevant |