Rajesh V

About Rajesh V

As the Sr. Clinical Quality leader, I steer and drive the quality initiatives of Global Sandoz Clinical development in addition to quality oversight and management of global clinical development projects. I have over 10 years of experience in clinical quality assurance, clinical quality control, audit and inspection management, digitalization, training, data privacy, and data integrity in the pharmaceutical industry. My prior assignments include clinical monitoring, TMF management, project management, study start up, site activation and site monitoring My mission is to drive the organization towards a quality mindset by implementing quality-oriented strategies that achieve business excellence and competitive advantage. I have successfully managed and improved the quality systems, processes, and standards for multiple global clinical trials, vendors, and computerized systems, ensuring compliance with regulatory requirements and industry best practices. I have also trained and empowered my team and stakeholders on quality principles, tools, and methodologies, fostering a culture of continuous improvement and innovation.

Experience

1. Sr Manager Clinical Qa

   Sandoz India

   Mar 2024 — Present · Hyderabad, IN

Education

• Sri Ramachandra Medical College and Research Institute

  B.Pharmacy, Pharmaceutical Sciences

  1996 — 2000

• Annamalai University

  M.Pharmacy, Industrial Pharmacy

  2001 — 2003

Skills

• Clinical Trials
• Sop
• Clinical Development
• Clinical Research
• Clinical Operations
• CRO
• Ich-Gcp
• V&V
• Edc
• Therapeutic Areas
• Ctms
• Oncology
• Regulatory Submissions
• Regulatory Requirements
• Gcp
• Clinical Monitoring
• Pharmacokinetics
• Pharmacovigilance