Your role

• Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerised systems
• Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance
• Provide estimates and forecast validation activities for a project
• Author validation plans/reports, reviews test plans/reports (and other deliverables) to asses and notify that system is ready to go life
• Determine testing strategy, requirements and acceptance criteria
• Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
• Coordinate and advise on all validation activities on a global level/organizational level for system/project
• Participate actively in validation discussions, provide consultancy for all validation related questions
• Participate in system implementation and maintenance planning
• Lead and author system and functional risk assessments
• Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions
• Review and collect expected CSV deliverables, records and other evidences according to plans
• Prioritize activities in line with the project schedules, business needs and compliance requirement
• Ensure code release to production and maintenance procedures are identified and adhered
• Confirm initial data loading and/or data migration from other systems, are performed according to approved procedures
• Assess changes to determine potential impact to the validated state of the computerised system
• Support system maintenance with validated state and permanent audit readiness
• Lead and author system periodic review according to procedure
• Observe governance processes, escalates area for improvement
• Support system audit/inspection preparation and execution as CSV subject matter expert
• Assures strategic/essential oversight over validation support within department and provides support/consultancy for the team and within global organization if necessary.
• Implements relevant framework and processes, propose and uses tools
• Providing training and validation/quality knowledge/experience exchange support
• Prepares recommendations for process optimization in his/her area of influence
• Provide input and guidance for a computerized system retirement planning