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Assessed and reviewed the validation (CSV) documentation: URS, FRS, IQ, OQ, PQ, Risk analysis, Validation Plan, Tests, and Validation Summary Report.
Improved MasterControl eQMS implementation based on incidents, deviations, and change requests.
∙ Managed and aligned the team resources of 13 Technical Writers and Assistants with Company strategic objectives.
∙ Led the project for restructuring, migrating the documentation (20,000 pages) to a new validated authoring system (Author-it).
∙ Developed a 3-5 year KM vision for Technical R&D, including a strategic plan and best practices in documentation to support the development process.
∙ Conducted a market study to identify the best advanced research tool based on Machine Learning and AI for increasing search efficiency by 23% in several million documents in global R&D.
∙ Digitalized critical forms.
∙ Implemented streamlined business and document management processes to oversee and review regulatory submission dossiers in electronic format, ensuring compliance (eCTD, CSV) with regulations across multiple regions
worldwide (US, EU, Japan, China).
∙ Spearheaded the IT development of e-knowledge initiatives and the learning strategy for dozen of the worldwide
vaccine business units (US, EU, Asia, Africa, etc.).
∙ Pioneered the development of the first Intranet platform dedicated to sharing comprehensive clinical trial results.
∙ Spearheaded the re-engineering of processes for non-commercial manufacturing activities.
