Kavitha . Email & Phone Number

Rensselaer, New York, United States

- Document validation plan and IQ/OQ/PQ protocols in compliance to FDA regulatory guidelines- Writing and executing cleaning validation and equipment qualification (IQ/OQ) protocols and final reports, including assessing protocol deviations. - Responsible for documentation work throughout the computer system validation process using Agile

- Responsible for reviewing and approving Validation protocols.- Involved in documenting and executing Test plan, Test cases and Test scripts.- Created User Requirement Specification (URS) and Functional Requirements Specifications (FRS) - Ensure that documentation and operations meet established requirements of cGMPs, internal SOPs and company policies.- Support Building Management System (BMS) investigations- Assisted in development of Risk Assessment of FMS using Six Sigma Principles.- Trained QA personnel in executing test script and test plans- Execute IQ and PQ test scripts as per QMS.

Hyderabad Area, India

- Involved in GAP analysis- Participated in peer reviews of document documentation- Equipment validation of GC-MS, HPLC, Ovens and other heavy equipment in compliance with FDA regulations- Documented and reviewed Standard Operating Procedures