Computer System Validation (CSV) Lead-GxP
- Montreal, QC, Canada
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Job details
- Job type
- Contract
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- Posting language
- English
- Posted
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
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
Categories
- Technology
- Software
- 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
- KRAs
- KPIs
- Privacy Requirements
- Third-Party Audits
- Client Management