Quality assurance management

The organization chart shown in Figure 6.3-2 shows the Quality Assurance Manager high in the organization, to achieve independence of QA as required by 10CFR50 Appendix B. 

Quality Assurance Manager Allergan Pharmaceuticals Irvine, California... 

Employee previously rewarded for deviating from the procedure, due to a culture of rewarding speed over quality, resulting from and reflecting a defective quality-assurance management system... 

It is the responsibility of the quality assurance manager to develop and maintain the validation program. The departmental managers and contractors are responsible for the SOP compliance. 

It is the responsibility of all supervisors, validation officers, engineers, and managers to follow the procedure. The quality assurance manager is responsible for SOP compliance. 

All validation activities through the different progress steps should be coordinated by one person, preferably the quality assurance manager. 

The departmental manager will initiate a process change request form prior to any change in the approved and authorized procedure. The form will be forwarded to the quality assurance manager to review and approve. 

The calibration manager is responsible for establishing an adequate and organized calibration program. Supervision of the whole program should be done by the quality assurance manager. 

If all requirements have been satisfied and all validation documents have been approved, the quality assurance managers may release the water system for production use. 

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