GxP Compliance & Computerised System Validation (CSV) Consultant

About the role

An integrated ERP and pharmaceutical operations management platform is being developed for a pharmaceutical manufacturing client. The company is looking for an experienced GxP compliance and computerised system validation (CSV) consultant to bridge the gap between software engineering, pharmaceutical quality systems and validation. The consultant supports the design, review, testing, documentation and validation readiness of the platform, working closely with software engineers, the QA/validation team and process owners.

Key responsibilities

• Advise on applicable GxP requirements and pharmaceutical computerised system controls
• Review ERP workflows against pharmaceutical manufacturing and quality processes
• Support URS, FRS, risk assessments and validation plans
• Guide IQ, OQ, PQ, UAT and associated validation documentation
• Advise on data integrity, audit trails, electronic signatures, access controls, segregation of duties and document control
• Review electronic batch records, traceability, quality management, deviations, CAPA and change control
• Help set up requirements traceability, test evidence management and validation documentation practices
• Identify compliance gaps, recommend corrective actions and assess validation readiness
• Contribute to SOPs, user training and procedures for maintaining the validated state

Required profile

• Demonstrable experience in pharmaceutical manufacturing, QA, quality systems, regulatory affairs or a related GxP environment
• Practical understanding of GMP and pharmaceutical quality management
• Experience or competence in computerised system validation and validation documentation
• Strong documentation, analytical, communication and stakeholder management skills

Required skills

• GAMP 5 and risk-based validation (desirable)
• FDA 21 CFR Part 11 and EU GMP Annex 11 (where applicable)
• ICH and PIC/S guidance (where applicable)
• ERP, MES, QMS, LIMS, EDMS or electronic batch record systems (desirable)

This is a project-based consultancy engagement; scope, time commitment, deliverables, duration and fee are agreed with the candidate. Applications with a CV and a brief summary of relevant experience are sent by email by 16 November 2026.