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BURGEON IT SERVICES

Computer System Validation (CSV) Lead-GxP

Montreal, QC, Canada

Contract

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Job details

Job type: Contract
Apply by: Dec 4, 2026
Posting language: English
Posted: Nov 4, 2026

Original job description

Role: Computer System Validation (CSV) Lead-GxP

Location: Montreal _ Canada - Hybrid

Duration: Long Term

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

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More about this job

Responsibilities

Lead validation of GxP computerized systems, including creating validation plans and reports and reviewing system validation documents. Oversee compliance policies, audits, quality assurance, CAPA, metrics, and team delivery, while supporting data migration activities for the SAP ecosystem.

Requirements

The role calls for a senior-level resource with expertise in GxP computerized system validation, GAMP 5, and compliance across GMP, GCP, GLP, and privacy requirements. It also requires experience with validation documentation, audits, CAPA, team management, and SAP ecosystem data migration.

Skills

Computer System Validation
GxP Compliance
GAMP 5
Validation Planning
Quality Assurance
Information Security
Compliance Auditing
Data Migration
SAP
CAPA
Quality Metrics
Team Management
Conflict Resolution
Client Management

Visa sponsorship

Not detected in the job text

Keywords

Computer System Validation
CSV
GxP
GMP
GCP
GLP
GAMP 5
SAP
Data Migration
Validation Plan
Validation Report
URS
FS
FRA
DD
IQ
OQ
PQ
TRM
Information Security
Quality Assurance
Compliance Audits
CAPA
Quality Metrics
Privacy Requirements
Third-Party Audits
KRAs
KPIs
Policy Framework

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