CSV Compliance Consultant

Location: Cambridge  |  Cambridgeshire  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHCSV
Salary: £50000 - £100000
Job Status: Contract / Full Time

I am looking for CSV-IT Compliance Consultant for 6 months in Cambridge who is looking for a challenge and change, and who want to make a difference through the delivery of results.

To provide compliance support for the Infrastructure Services (IS) Compliance function, responsible for providing assessment and assurance. The role holder will work proactively as part of a team responsible for the generation and execution of IT infrastructure qualification documentation to enable conformance with associated regulations (e.g. GxP, US FDA 21 CFR Part 11 and SOX).


Minimum of 5 years’ experience working in an IT compliance or computer system validation role within a pharmaceutical, regulated or ISO environment

Educated to degree level or equivalent, in an IT field, or equivalent technical discipline

Knowledge and understanding of IT best practices and IT quality Management Systems (such as ITIL, ISO).

Knowledge and understanding of cGxP, GAMP5, 21 CFR Part 11, SOX and other relevant regulations, and the importance of quality.

Knowledge of enterprise-class IT technologies including networks, security features, backup/data recovery procedures and strong understanding of IT concepts and terminology.

Knowledge of Active Directory, Group Policy management, DNS, DHCP, WSUS, and familiarity with a range of desktop and mobile operating systems, including Microsoft Windows, Apple iOS and Apple macOS.

Knowledge and experience of working with cloud based systems including IaaS, SaaS, PaaS etc. for the Pharma Industry

Working knowledge of the system design lifecycle, IT project management and development of validation/qualification documentation within a regulated environment

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.