Einführung

Aufgabenbeschreibung

• Accountable for local CSV & Quality deliverables defined for the local Deployment
• Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
• Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
• Coordinate and support adoption of local SOPs triggered by ASPIRE (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
• Supporting the training activities for ASPIRE
• Supporting test planning, execution, closure and defects
• Supporting data migration, esp., local verification and incidents associated with GxP data
• Supporting local cutover activities to ensure all protocols are completed and deviations accepted
• Supporting any definition of interim ways of working required during cutover
• Defining and supporting any PQ activities if required
• Compliance support for defects, incidents and change controls
• Coaching and training of local ASPIRE team as required in related compliance approaches/deliverables
• Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the ASPIRE project

Erforderliches Profil