Prashanth Kumar V

PHARMACEUTICAL QUALITY OPERATIONS: HEAD / VP / AVP / DIRECTOR

EXECUTIVE SUMMARY

An Accomplished pharmaceutical professional with global experience of over 23 years in diverse areas of pharmaceutical industry and within India as well as US.

I am an expert in quality systems development, implementation, regulatory audit, compliance, remedial actions, integration solutions. Hands on experience with Quality Control management, leading change in manufacturing operations and in improving organizational and operational efficiency.

Led several continuous improvement projects supporting technical and business process throughout the product life cycle management. I possess strong portfolio of successes orchestrating the start-up, growth of quality operations, laboratory, technical management with proven ability to develop, build and manage high performance teams and lead integration of such teams to insure efficiency, quality, customer service, and cost-effectiveness.

I am backed by solid credentials, agile with progressive, innovative, broad, and deep background with exceptional work ethics and commitment to organizational objectives. Contributed to various products development, manufacturing, quality, audit, compliance, regulatory and remediation for business sustainability and growth through a combination of strategic, tactical planning, initiative, and strong leadership.

Through growing global direct and indirect management roles, I have demonstrated the ability to develop and lead self-empowered and high-performing multicultural teams toward a shared ambition, to co-create with them the path to success and to deliver against it.

I challenge the status quo, encourage best practice sharing and foster innovative and cost-effective solutions through a test-and-learn approach, all this to create value for patients and customers. Fluent in English, mobile internationally, I wish to bring my experience, energy, and decision-making ability to an innovative, dynamic, and global life science company.

KEY WORDS: PHARMACEUTICAL INDUSTRY | QUALITY REMEDIATION | AUDITING AND COMPLIANCE | AUDIT MANAGEMENT | SUPPLIER PERFORMANCE | QUALITY SYSTEMS | DUE DILIGENCE | RISK ASSESSMENT | CAPA | DATA QUALITY | PRODUCT QUALITY | MANUFACTURING | QUALITY CONTROL | US FDA | EMA | QUALITY STRATEGY | REGULATORY INSPECTION | DATA INTEGRITY | GMP | ISO | GXP | REGULATORY REQUIREMENTS | MANAGEMENT SKILLS | LEADERSHIP | OPERATIONAL EXCELLENCE

• Legal Status: , PERSON OF INDIAN ORIGIN WITH US CITIZENSHIP