Validation Analyst

Hiring: Validation Analyst – Global Development

Location: Tokyo, Japan

Contract Opportunity

Industry: Biotechnology / Pharmaceutical

We are seeking an experienced Validation Lead with 5 years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), and GxP Compliance within pharmaceutical or biotechnology environments.

Key Skills:

• Computer System Validation (CSV) & Computer Software Assurance (CSA)
• FDA 21 CFR Part 11, EU Annex 11 & GAMP 5
• Data Integrity (ALCOA )
• Risk-Based Validation & CSA Transformation
• Validation Plans, URS, FRS, IQ/OQ/PQ, Traceability Matrix & VSR
• SDLC & GxP Compliance
• Audit & Inspection Readiness
• Change Control, Risk Assessments & CAPA
• Cross-Functional Project Leadership

Systems Experience:

• Veeva Vault (Strongly Preferred)
• CTMS
• eTMF
• Pharmacovigilance / Safety Systems
• Regulatory Publishing Platforms
• Biometrics & Statistical Computing Environments

Preferred Experience:

• Global Development, Clinical Development, R&D Systems
• Cloud-Based Platforms & Infrastructure Qualification
• Validation Automation Tools
• Agile Environment Experience