Computer System Validation - Senior Consultant

Canada (Montreal) – Hybrid

Minimum 10+

Deep expertise in CSV, Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.
Effectively contribute implementation of client contractual compliance requirements in the technology setup and delivery of GxP software.
Lead, review and guide the development team for InfoSec, Quality and Compliance related policy (ies) and supporting process, guidelines, standards to ensure execution of policy framework
Plan and ensure conducting of compliance audits, reviews, and reconciliation as part of compliance abidance.
Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.




Develop and establish quality assurance standards and measures for the information technology services within the organization.
Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.
Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
Plan, conduct and report routine and directed GxP audits including third party audits.
Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
Develop and records KRAs and KPIs for ensuring process effectiveness measurement
Effective utilization of resources in offshore.
Effective team management and conflict resolution.
Participate in Client management reviews
Need an experience resource to support the Data migration activities for SAP ecosystem

📌 Computer System Validation Senior Consultant Montreal (Canada)
🏢 Spruce InfoTech
📍 Canada