- 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 (CSV) Lead-GxP (Montreal)
🏢 Burgeon IT Services
📍 Montreal