Dhananjayan L

About Dhananjayan L

Pharmaceutical validation leader with 19+ years of experience in sterile injectables…

Experience

1. Senior Group Leader

   Mylan

   Jul 2015 — Present · IN

   Involved In Preparation, Review, Compilation & Summarize of - Computer System Validation (CSV)as part of GxP Impact assessment, GxP risk Assessment, GAMP Categorization, 21 CFR Part 11 Assessment, Risk analysis & FMEA preparation, review and compliance of equipment/systems as part of computerized system Validation- Equipment\'s/Systems, Impact Assessment (IA), User Requirement Specification (URS, Factory Acceptance test (FAT), Site Acceptance test (SAT)/Commissioning- Quality Risk Management (QRM),Qualification Trace Matrix (QTM), Trial Run, miscellaneous study protocol preparation & mitigation compliance of all equipment\'s/ Systems. Design Qualification (DQ), Installation & Operational Qualification (IQ/OQ/ IOQ), and Performance Qualification (PQ) protocols for Equipment\'s /Systems.QMS- Change control handling as a part of qualification and validation- CAPA investigation, root cause, effectiveness checks and implementation- Identify the cause of Deviation & Investigate- Co-ordinate with user department & Investigate the root cause analysis. Supporting to regulatory and Compliance departments and report any non-conformities to the Senior/ Management

Education

• University of Madras

  Master's degree

  2005 — 2007

• Madras University

  Bachelor's degree

  2000 — 2003