Assist users and T in translating user requirements for systems into testable functional and system specifications for software and hardware. Coordinate computer validation projects, ensuring internal Standard Operating procedures and regulatory requirements are addressed. Lead vendor audits. Conduct internal audits of validation processes, documentation, change control, etc. Host FDA computer audits and follow-up.
Evaluate resource needs.
Provide training and support to use groups pertinent to regulatory requirements and purpose of validation activities. Bachelor s degree in technical area or computer science. At least 8 years experience in the pharmaceutical industry in the areas of system development and validation, quality assurance, or regulatory compliance. Familiarity and experience with FDA Regulation CFR Part 11 is required. This position is based in the United Kingdom.