GxP Compliance & Computerised System Validation Consultant

About the role

We are seeking a knowledgeable GxP Compliance & Computerised System Validation (CSV) Consultant to support the design, review, testing, documentation, and validation readiness of our pharmaceutical ERP platform. The role bridges software engineering, pharmaceutical quality systems, and regulatory requirements.

Key responsibilities

• Advise on applicable GxP requirements and computerised system controls.
• Review ERP workflows for alignment with manufacturing and quality processes.
• Develop and review URS, FRS, risk assessments, and validation plans.
• Guide preparation and review of IQ, OQ, PQ, UAT and related documentation.
• Ensure data integrity, audit trails, electronic signatures, role‑based access and segregation of duties.
• Identify compliance gaps, recommend corrective actions and assess validation readiness.

Required profile

• Experience in pharmaceutical manufacturing, QA, Quality Systems or Regulatory Affairs.
• Practical understanding of GMP and pharmaceutical quality management.
• Competence in computerised system validation and documentation.
• Strong analytical, communication and stakeholder management skills.

Required skills

• GAMP 5 and risk‑based validation.
• FDA 21 CFR Part 11 and EU GMP Annex 11.
• ICH and PIC/S guidance.
• ERP, MES, QMS, LIMS, EDMS or electronic batch record systems.
• Requirements traceability, test protocols and evidence management.