General requirements for personnel
Article 9
1. At each manufacturing site there shall be a sufficient number of personnel with the necessary qualifications and practical experience having regard to the intended operations. The individual responsibilities of personnel shall be clearly laid out. 2. Key personnel, including the qualified persons referred to in Article 97 of Regulation (EU) 2019/6, the head of production, the head of quality control and, where applicable, the head of quality assurance or the head of the quality unit shall be appointed by senior management. They shall be given sufficient resources to fulfil their duties. 3. The duties of the key personnel shall be clearly defined in job descriptions. The hierarchical relationships shall be set out in an organisation chart. There shall be no gaps or unexplained overlaps. The head of production shall assume responsibility for the activities set out in Chapter VI, as well as for the training of personnel and the qualification and maintenance of equipment and premises used for production. The head of quality control shall be responsible for the quality control operations set out in and for the training of personnel. 4. The heads of production and quality control shall be independent from each other. In large organisations, it may be necessary to delegate some of their tasks. However, such delegation of tasks shall not imply a delegation of responsibility. Additionally, depending on the size and organisational structure of the company, a separate head of quality assurance or head of the quality unit may be appointed. In that case, the responsibilities of the heads of production and quality control may be shared with the head of quality assurance or the head of the quality unit. 5. Consultants shall have adequate education, training and experience to advise on the subject for which they are retained. Records of the qualifications and type of service provided by consultants shall be kept.