GxP CSV Consultant for Pharma Tech Due Diligence (Remote)

Intelance; Greater London; Remote; GBP 101,000 - 129,000; Full time

Job summary

Intelance, a UK-based technology, AI and cyber assurance firm, is seeking a freelance due diligence reviewer to assess GxP validated software used in drug development. You will work remotely in the UK, with occasional London meetings, delivering findings for client reports.

The role requires deep experience in computerised system validation, GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and CDISC standards, with the ability to produce clear, actionable fixes for potential deal-impacting issues.

Qualifications

• At least five years of computerised system validation in a GxP setting.
• Hands-on use of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.
• Experience validating or auditing systems that produce clinical trial or regulatory submission outputs.
• Working knowledge of CDISC data standards.
• Clear, plain writing that founders, buyers and lawyers can follow.
• Experience validating systems that use machine learning or AI is a strong plus.

Responsibilities

• Review the validation approach, records and evidence for platforms that produce clinical trial and real world evidence outputs.
• Check audit trails, access controls, electronic records and change control against 21 CFR Part 11 and EU GMP Annex 11.
• Judge whether the validation is proportionate to risk, using GAMP 5 and Computer Software Assurance thinking.
• Check how validation is kept current when AI workflows and machine learning models change.
• Check that outputs follow the expected data standards, such as CDISC SDTM and ADaM.
• Rate each finding by how it could affect the deal, and write clear, practical fixes.

Skills

GxP validation

GAMP 5

21 CFR Part 11

EU GMP Annex 11

CDISC data standards

AI/ML experience

Clear writing

Job description

Intelance, a UK-based technology, AI and cyber assurance firm, is seeking a freelance due diligence reviewer to assess GxP validated software used in drug development. You will work remotely in the UK, with occasional London meetings, delivering findings for client reports.

The role requires deep experience in computerised system validation, GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and CDISC standards, with the ability to produce clear, actionable fixes for potential deal-impacting issues.