Paul Kennedy
Senior Consultant, Global Data Integrity @Merck Group
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WORK HISTORY
Senior Consultant, Global Data Integrity @Merck Group
Manage the lifecycle of all GxP computerised systems for Merck\'s testing and manufacturing sites in the UK, US and Singapore sites, ensuring compliance with relevant business and regulatory requirements.• Overseeing software assurance programs, including qualification, validation, user access, audit trail review, configuration management, change/deviation/CAPA management, vendor selection, customer/regulatory audit readiness, disaster recovery and business continuity. • Acting system and process owner for GxP systems used to enhance data integrity assurance of relevant GxP workflows.• Develop and maintain roadmap for software assurance improvements, leading projects and change initiatives.
EDUCATION
Newcastle University
Bachelor of Science, Physiological Sciences
SKILLS
ABOUT PAUL KENNEDY
Experienced technical and quality leader in the regulated pharmaceutical, life science and biotechnology sectors - looking to continue development into senior leadership roles. Expertise in implementing and overseeing complex technical solutions with a focus on GxP compliance, Computer Software Assurance (CSA), Computer System Validation (CSV), QA oversight and data integrity assurance. Proven success in people management, operational excellence, new product/equipment onboarding and continuous process improvement. Experienced in executing large-scale technical projects and CAPEX initiatives while maintaining a strong commitment to advancing compliance and technical excellence in regulated environments.Providing a comprehensive understanding of industry standards and best practices, including regulations such as EudraLex Volume 4 (Annex 11, Annex 15 and Annex 22), US Code of Federal Regs. 21 CFR Part 11, Part 58, Part 210, Part 211, ICH E6, ISO9001, ISO13485, ISO14971, ICH Q7, Q8, Q9, Q10, GAMP 5, Computer Software Assurance (CSA) and ALCOA++.
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