Extensive experience with driving improvement, from ideation through realization phases for delivering improvements for Productivity, Effectiveness, Efficiencies of business processes and compliance to Regulatory requirements. Complete life cycle management of the for R&D Quality systems for diverse dosage forms, including Design Controls for Combination products through phases of risk management, experiment design ( DoE ), Reports / Documentation from process design & development, technology transfer and regulatory submissions & inspections.Successful projects in Automation of systems and processes in Quality Assurance & Quality Control ( ELN, LIMS, SAP QM, QMS DMS, LMS )