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)
🏢 Spruce InfoTech
📍 Montreal