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GxP Infrastructure Validation Specialist | Contract | Remote UK
I'm supporting a global pharmaceutical client on a major SAP S/4HANA transformation and need two validation specialists to qualify the infrastructure behind it.
The infrastructure teams do not yet operate under GxP governance, so this is a chance to qualify the platforms and help put working controls in place, to a strategy set by the programme's GxP Validation Lead.
What you will do:
• Author qualification plans, risk assessments, IQ protocols and qualification reports
• Qualify cloud and hosted platforms, servers, networks, backup and restore, disaster recovery and access management
• Draft the procedures and templates infrastructure teams need to work in a GxP controlled way
• Support supplier and hosting provider assessments
What you will bring:
• GxP IT infrastructure qualification in pharma, biotech or medical devices
• GAMP 5, the GAMP IT infrastructure guidance, EU GMP Annex 11 and 21 CFR Part 11
• Qualification of cloud or hosted environments
• The ability to explain GxP requirements to technical teams new to them
Azure, AWS, ITIL or SAP hosting experience is a strong plus.
Start: November or December 2026
Remote UK with occasional workshops. Contract, inside IR35. Initial six months with extension expected.
If this looks relevant, message me directly or apply.
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