8-10 years of experience in Computer System Validation (CSV)
Strong knowledge of GxP regulations and validation frameworks
Experience with CAPA and deviation management
Skilled in documentation and the validation lifecycle
Understanding of life sciences domain processes
Responsibilities
Perform CSV activities in compliance with various regulatory standards
Ensure readiness for audits and inspections
Conduct periodic reviews and audit trail assessments
Manage deviations and compliance with policies
Author and review critical validation documentation
Implement risk-based validation and testing
Support the entire validation lifecycle from planning to closure
Collaborate with cross-functional teams across the life sciences
Benefits
Opportunity to work in a GxP-compliant environment
Exposure to various life sciences systems and platforms
Collaboration with diverse teams across functions
Focus on audit readiness and compliance
Engagement in regulatory-focused activities
Full Job Description
Job Summary:
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems.
Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.
Roles & Responsibilities:
Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.
Ensure audit and inspection readiness.
Conduct periodic reviews, access roster reviews, and audit trail reviews.
Manage deviations, CAPA processes, SOP, and policy compliance.
Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
Perform risk-based validation and testing aligned with CSA (Computer Software Assurance).
Support validation lifecycle from planning to execution and closure.
Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.
Education & Experience:
8-10 years of experience in Computer System Validation (CSV).
Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles.
Experience with CAPA, deviation management, SOP, and policy compliance.
Strong documentation and validation lifecycle experience.
Good understanding of life sciences domain processes.
