John L Email & Phone Number

An experienced Computer Systems Validation specialist with a proven track record of 25+ years working with international life science companies in a global matrix environment.Evaluates and recommends effective and appropriate quality approaches for IT Infrastructure Qualification and Applications Validation (CSV) amidst complex IT landscapes and scenarios, including cloud solutions.Supports quality management, documentation, testing and training in regulated environment according to FDA, European regulations and corporate standards in the following areas: - Quality Manual- IT Project Management Methodology- Information Management Framework- GxP, ERES, SOX, Data Privacy- Information Security- Confidentiality, Integrity, Availability- Business Continuity, Disaster Recovery- Records Management, Mobile Application- Public Facing Website / AppDevelops and defines IT system management processes.Provides extensive inputs for user adoption, deployment, training and communication strategies.Authors the full range of System Lifecycle and Project Documents.IT Process Know-howCSV, IT Infrastucture Qualification, IT Application Validation, QMS, Information Risk Management, IT System Classification, IT Service Management, Document Management, Training Management, Records Management, Third Party Assessment, Gap and Vulnerbility ManagementRegulatory Areas21CFR Part11 / EU GMP Annex 11, 21CFR Part 820, Data Integrity (FDA 21CFR Parts 210/211/ 212), Data Privacy (GDPR)Industry StandardsGAMP5, ITIL v3, Prince 2

Listed skills include Information Technology, Pharmaceutical Industry, Change Management, Infrastructure, and 42 others.

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  Cork Institute Of Technology

  Chemical And Process Engineering