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GxP Infrastructure Validation Specialist
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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
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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
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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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