DEVELOPING INNOVATIVE STRATEGIES
RIGHT FIRST TIME & EVERY TIME
Supporting higher management to identify and delivering strategic and transformational Quality leadership drive for imparting Culture of Pharmaceutical Quality to provide successful international growth initiative in Pharmaceutical, Healthcare, Cosmetics.
Deliverables and achievements –
Provide effective compliance strategy and QIP (Quality Improvement Plan) for Quality Management of - Pharmaceutical/ Cosmetics (API), Biosimilars, Drug- Device combination products, Devices, Drug Substance, Drug Formulation, in Manufacturing and R&D operations. Services provided to various clientele- API, DF, Devices, IT.
Providing the desired support for steering organization through complex Quality & Regulatory challenges, remediation, transitions. Help identify and build an empowered Quality & Operations Team which is capable and empowered to deliver results within highly competitive products and regulatory environment. Effective implementation of Quality Systems including oversight of IT applications such as Tracwise®, Documentum®, LMS®.
Training - GxP compliance
Audits - GxP
Pre-approval inspection (PAI) readiness
Operational readiness and sustainability programs (mentoring)
Formulation of CAP – corrective action plan
Assistance during regulatory inspections & post-inspection correspondence and meetings
Assistance to legal counsel in FDA enforcement matters
Due diligence of product and facility acquisitions
Udaykumar K. Rakibe, Ph.D.
Udaykumar is a quality professional with a dynamic career. Steering organizations through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in the cross-cultural environment within highly competitive products and regulatory environment.