GAMP 5
Ability to apply GAMP 5 practices and professional judgment to deliver reliable outcomes in quality & regulatory contexts.
Qué significa cada nivel
La escala P1–P5 es común a todas las habilidades, pero lo que significa cada nivel cambia según la habilidad. Esto es lo que se espera observar.
P1
Describes the process, controls, stakeholders and basic decisions involved in GAMP 5.
P2
Executes standard GAMP 5 activities accurately within established controls and escalates exceptions.
P3
Owns complex GAMP 5 cases/processes, improves controls and coaches colleagues.
P4
Sets cross-team standards and governance for GAMP 5, integrating risk, metrics and stakeholder needs.
P5
Defines enterprise strategy or external practice for GAMP 5 and develops other experts.
Fuente: PROCOMER FTZ employer benchmark