Senior Consultant – Computer System Validation (CSV) Montreal, Canada (Hybrid)
- Montreal, QC, Canada
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Job details
- Job type
- Contract
- Apply by
- Experience
- Experience: 10+ Years
- Posting language
- English
- Posted
Original job description
Job Title: Senior Consultant – Computer System Validation (CSV)
Location: Montreal, Canada (Hybrid)
Duration: 12 months, plus extensions
Experience: 10+ Years
Domain: Pharma / Healthcare / Life Sciences
Job Description:
We are looking for an experienced Senior Consultant with strong expertise in Computer System Validation (CSV), GxP compliance, and GAMP 5 guidelines to support validation activities and SAP ecosystem data migration.
Mandatory Skills:
- Strong hands-on experience in Computer System Validation (CSV).
- Deep knowledge of GxP (GMP, GCP, GLP) regulations.
- Strong understanding of GAMP 5 guidelines.
- Experience validating GxP computerized systems.
- Hands-on experience preparing and reviewing URS, FS, FRA, DD, IQ, OQ, PQ, and TRM documents.
- Experience creating Validation Plans and Validation Reports.
- Knowledge of quality assurance, compliance audits, and CAPA.
- Experience supporting SAP ecosystem data migration.
- Strong Pharma / Healthcare / Life Sciences domain experience.
More about this job
Responsibilities
Support Computer System Validation activities for GxP-regulated computerized systems and assist with SAP ecosystem data migration. Prepare and review validation documentation, including requirements and testing documents, validation plans, and validation reports.
Requirements
Requires 10+ years of experience and strong hands-on expertise in CSV, GxP regulations, and GAMP 5 within the pharma, healthcare, or life sciences domain. Candidates should have experience validating GxP systems, preparing and reviewing validation documentation, supporting quality assurance, audits, and CAPA, and assisting with SAP ecosystem data migration.
Skills
- GxP Compliance
- GMP
- GCP
- GLP
- GAMP 5
- GxP Computerized System Validation
- URS, FS, FRA, DD, IQ, OQ, PQ, and TRM Documentation
- Validation Plans and Reports
- Quality Assurance
- Compliance Audits
- CAPA
- SAP Ecosystem Data Migration
- Pharma, Healthcare, and Life Sciences
Visa sponsorship
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Categories
- Consulting
- Healthcare
- Technology
- Management & Leadership
Keywords
- GxP
- GMP
- GCP
- GLP
- GAMP 5
- Pharmaceuticals
- Healthcare
- Life Sciences
- Computerized Systems
- URS
- FS
- FRA
- DD
- IQ
- OQ
- PQ
- TRM
- Validation Plans
- Validation Reports
- Quality Assurance
- Compliance Audits
- CAPA
- SAP
- Data Migration