Description
Compliance and Validation SME required for a large Programme based in the UK on a Contract basis for 6 months initially, with potential extensions.
You will need to be a proven, hands on Compliance & Validation with 8-10 years' experience of Compliance and Validation.
Required Skills:
* 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 Deliverables meet the compliance/GDP standards.
* Good understanding of Life Sciences Domain and processes.
* Process and Equipment validation experience is desirable.
All of our opportunities require that applicants are eligible to work in the specified country/location, unless otherwise stated in the job description.