Validation Lead || Poland || Contract- Remote || €200/day

We are seeking an experienced Validation Lead to support validation activities across GxP-regulated IT systems and processes. The role requires strong experience in CSV (Computer System Validation), SDLC compliance, and documentation aligned to pharmaceutical/life sciences standards. You will act as the point of contact for validation within project teams and ensure all deliverables meet regulatory and internal quality requirements.

Key Responsibilities:

• Lead and coordinate validation activities for IT systems and applications in GxP environments
• Develop and maintain validation documentation (VMP, URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, Validation Reports)
• Ensure compliance with relevant regulatory guidelines (e.g., 21 CFR Part 11, EU Annex 11) and internal SOPs
• Collaborate with QA, IT, and business stakeholders to ensure validation alignment with project goals
• Review and approve validation documentation produced by vendors or internal teams
• Support audits and inspections by regulatory authorities or clients
• Provide guidance on validation best practices and change control processes

Required Skills & Experience:

• 5+ years of experience in Computer System Validation (CSV) or IT Validation
• Strong understanding of GxP, SDLC, and risk-based validation approaches
• Familiarity with pharma/biotech regulatory requirements and industry standards
• Experience leading validation for IT systems (e.g., ERP, LIMS, MES, Document Management Systems)
• Excellent written and verbal communication skills in English
• Ability to work independently in a remote, cross-functional environment