Computer System Validation - Senior Consultant
- Montreal, QC, Canada
Contract
Applications open in a new tab.
Job details
- Job type
- Contract
- Apply by
- Posting language
- English
- Posted
Original job description
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
More about this job
Responsibilities
Lead validation of GxP computerized systems, including creating validation plans and reports and reviewing validation documentation. Establish and maintain quality and compliance processes, conduct audits, support CAPA and quality metrics, and assist with SAP ecosystem data migration.
Requirements
The role requires at least 10 years of experience and deep expertise in computer system validation for GxP environments. It also calls for knowledge of GAMP 5, GxP and privacy requirements, validation documentation, audits, and SAP data migration, along with leadership and client-management capabilities.
Skills
- Computer System Validation
- GxP Compliance
- GAMP 5
- Validation Planning
- Quality Assurance
- Information Security
- Compliance Auditing
- Data Migration
- SAP
- Corrective and Preventive Action
- Quality Metrics
- Team Management
- Conflict Resolution
- Client Management
Visa sponsorship
Not detected in the job text
Categories
- Technology
- Consulting
- Management & Leadership
- Software
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
- Privacy Compliance
- Compliance Audits
- Third-Party Audits
- CAPA
- Quality Metrics
- KRAs
- KPIs
- Client Management