Simon James I.T. Ltd Leeds, Yorkshire, United Kingdom
Compliance & Validation SME, CSV My client, a leading Life Sciences company, is looking for a Compliance & Validation SME to join their Leeds based team. Experience required ; 8-10 years of experience with Compliance & Validation with expertise in Computer Systems Validation (CSV) Good understanding of regulatory requirements and industry standards - including 21 CFR Part 11 (Part 11), cGMPs, GDPs, GLPs, and GCPs for computerized 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. Experience with Validating Cloud Infrastructure and Cloud Applications is big plus. Collaborate with Delivery teams in ensuring the Deliverable meet the compliance/GDP standards. Good understanding of Life Sciences Domain and processes. Process and Equipment validation experience is desirable. Please apply for more information.