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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 3, 2026
Posting language: English
Posted: Nov 3, 2026

Original job description

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 and compliance activities for GxP computerized systems, including creating and reviewing validation plans, reports, and supporting documentation. Conduct audits and reviews, maintain quality and compliance processes, support SAP ecosystem data migration, and manage team and client activities.

Requirements

The role calls for mid-to-senior experience in GxP computerized system validation, quality assurance, and compliance, including familiarity with GAMP 5 and validation documentation. Experience supporting data migration in an SAP ecosystem is also needed; no education requirement is specified.

Skills

Computer System Validation
GxP Compliance
GAMP 5
Validation Documentation
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
KRAs
KPIs
Privacy Requirements
Third-Party Audits
Client Management

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