Rupesh Patel Email Address

Product Quality Complaint Lead, Associate Director

Otsuka in the U.S. From a family business to a global pharmaceutical business. Research and development of new pharmaceutical products and Digital Medicine. Fulfil your dreams with a career in pharma at Otsuka.

•Self-directed and energetic leader with strong track record of building high performing teams and maintaining quality systems such as Material disposition of Raw material, and Drug Product (Internal and external manufacturing), Packaging, Investigation/Deviation, CAPA management and Change Management, Product Complaints and Audits associated with Clinical and Commercial pharmaceutical products. •Comprehensive knowledge of all aspects of cGMP Quality Assurance and regulatory compliance activities with emphasis on continuous improvement and sustained compliance. •Participated , Lead and supported as SME the FDA and EU GMP (Swedish Health Authority MPA) inspections. •Facilitated and managed the investigation/deviation/CAPA processes at the facility. •Developed and applied metrics, from measurement against standards, for the ongoing assessment of functional area quality and compliance, such as audits,investigations/Deviation/CAPA, and clinical supply. •Provided QA oversight of all Research Quality Systems. •Ensure GMP compliance of all research manufacturing and testing activities conducted by Pharmaceutics and Analytical Sciences including those conducted at external facilities. •Experience in Lean six sigma tools and Yellow belt certified. •Provided Quality Assurance release of all clinical batches ••Demonstrated achievement in leading multiple global teams in applying corporate standard Quality System improvement techniques for system re-engineering which resulted in substantial efficiency gains for the organization. •Received many “Excellence Awards” for leading Continuous Improvement Team. •Skilled manager with diverse background including manufacturing, packaging, quality assurance and regulatory, Over 15 years of direct managerial experience, overseeing strategic and operational aspects of groups as large as 22+ colleagues. Committed to proactive staff development, training, and mentoring •Goal driven, action oriented and Compliance mindset