Overview
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Under the direction of the Head, Data Systems QA, the primary responsibility of the Data Systems QA & Compliance Specialist will be to support the R&D Quality Compliance & Systems function by providing QA&C support of computer system validation (CSV) activities in Research & Development. The Data Systems QA & Compliance Specialist will assure compliance with applicable GxP regulations and standards (SDLC); advising the R&D IT Business Partner and R&D system owners/management on risk-related matters pertaining to R&D systems; and conducting audits to identify overall trends and areas of risk for systems in use within R&D as well as those externally in use by R&D service providers.
Key responsibilities for this role are to provide professional expertise and guidance in applicable regulations (e.g., 21 CFR Part 11, Annex 11, and ICH E6(R2)) and industry standards (e.g., ISPE GAMP 5) as applicable to R&D GxP environment (GCP, GLP, GVP, GDP). Additional duties include but not limited to liaising with various internal R&D functions, IT, and contract auditors and assisting stakeholders in maintaining systems within a state of compliance while providing recommendations for process improvement.
Responsibilities
Delivery of Validation Support
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