Computer System Validation (CSV) Lead-GxP
- Montreal, QC, Canada
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- English
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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
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
Categories
- Technology
- Management & Leadership
- Consulting
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