Karthik V

About Karthik V

I am working for Par Active technologies pvt ltd (An API unit of Endo Pharmaceuticals)…

Experience

1. Sr Associate-quality Assurance Compliancewire Functional Area Administrator Trackwise Mastercontrol

   Par Health

   Dec 2013 — Present · Chennai, IN

   Compliancewire training management system Functional area administrator, creation of user groups, related curriculum and addition of users, Uploading training material and quiz, Managing and handling of assignments and followup of user reports, Followup with users for timely completion of individual assignments etc.Handling of Change controls, deviations and other Quality management system related documents through TrackwiseTrackWise is a quality management system (QMS) software platform. It is used by midsize, large, and multinational companies in regulated industries to improve product quality, achieve regulatory compliance, and reduce risk.Manufacturing, quality assurance, and regulatory affairs professionals use it to centralize processes and automate reporting within their company and among global supply chain partners. TrackWise has been the leading quality management software platform since it was introduced in 1994. of Reports through Trackwise and followup with users for timely completion of QMS documents.Preparation of Annual product Quality review.Involving in Internal Audits.Handling of Master documents through Mastercontrol (QA Document controller)

Education

• Shanmugha Arts, Science, Technology and Research Academy

  Bachelor of Technology (B.Tech.), Biotechnology

  2004 — 2007

Skills

• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• Lifesciences
• Gmp
• Training Management
• Biotechnology
• Quality System Compliance
• Sop
• Quality System
• V&V
• Molecular Biology
• Standard Operating Procedure (Sop)
• Training
• Cleaning Validation
• Validation
• Change Control