Description
I am recruiting for a Compliance & Validation SME to be based in Leeds.
This role does fall inside IR35 so you must work through an umbrella company for the duration of the contract. The rate quoted on the job advert is the take home pay after ALL deductions.
You must have a number of years of experience with Compliance & Validation with expertise in Computer Systems Validation (CSV).
You will need a good understanding of regulatory requirements and industry standards - including 21 CFR Part 11 (Part 11), cGMPs, GDPs, GLPs, and GCPs for computerised system compliance.
Must have experience with FDA compliance of ERP (Oracle/SAP), Integrations, LIMS, Trackwise systems. Preferable experience Validating EDC, eQMS, laboratory instrumentation, and other business information systems.
Extensive experience in Qualifying Infrastructure & Software and has effectively developed & managed IQ/OQ/PQ plans and execution.
If this role is of interest please apply ASAP to discuss further.