Contact us at: [email protected] Focusing on startups and clients experiencing consent decree/warning letters. * Catering to USA and EU clients. * Quality Engineering, Project Management, Quality Assurance | Control, and Business Analysis in the FDA / EMEA regulated industries (i.e. Biotech : Pharma {API, Parenterals, Solid-dose}, Class 2A/2B/3 Medical Devices, IVD’s, Cosmeceutical and Neutraceuticals). * Focused on and experienced with computerized systems, lab & manufacturing equipment, lab instruments and systems, process, facility | utility, test methods, and cleaning validations. * Development of SDLC documentation and deliverables per ISPE GAMP5 Waterfall and Agile SCRUM methodology. * Performing DOE’s, gage R&R feasibility studies, system suitability, engineering studies, applying 6sigma principles. * Conducting audits, generating & conducting CAPA | IR | DR | OOS | OOT and resolving challenges by applying risk management tools. * Providing detailed & executive summaries, developing: project charters, project plans, master validation plans, progress metrics, final reports, and presenting recommendations. * Managing project budget, hiring/training employees, resolving issues/conflict, prioritizing project resources based on risk, business & effectiveness. * Providing team building, consulting, and training with respect to validation methodology, compliance, regulations, and quality engineering.