Glossary

Job Description

A document setting out the specific duties and authority of a person in a responsible position, so that there are no gaps or unexplained overlaps in responsibility.

Details

The job description is the document required by EU GMP Chapter 2 §2.3: the specific duties of each person in a responsible position are recorded, they are given sufficient authority to discharge those responsibilities, duties may be delegated to designated deputies of a satisfactory qualification level, and there should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP; §2.4 places ultimate responsibility for defining, communicating, and implementing roles, responsibilities, and authorities with senior management, and §2.5 requires the heads of production and of quality control to be independent of each other. If training is about whether a person can do the work and the organisation chart about who reports to whom, the job description settles what they are responsible for. Canadian inspections repeatedly cite job descriptions, authorities, and delegation that are inadequate or undocumented, including no signed job description, documents that differ from the work actually done, and unrecorded delegation leaving approval authority unclear.

Related sections

Related terms

Real inspection findings

See 181 findings that mention this term

Source

EU GMP Part I Chapter 2 §2.3 Personnel