Thulja Nikethani Reddy P.
Validation Specialist -iii @Curia
Signup · Get unlimited contacts
WORK HISTORY
Validation Specialist -iii @Curia
Burlington, MA, US
EDUCATION
Osmania University
Bachelor of Pharmacy - BPharm, Pharmacy
Southern New Hampshire University
Master of Science - MS, Health Informatics
University of the Cumberlands
Master of Business Administration - MBA, Health/Health Care Administration/Management
ABOUT THULJA NIKETHANI REDDY P.
As a Validation Specialist ( Sr. Validation Engineer)at Curia, I perform Commissioning and Qualification of various Computer systems, equipment, processes, and facilities for the pharmaceutical industry. I author and review Validation Protocols, Commissioning Plans, testing procedures, sample collection and analysis, and summary reports. I also support and represent the Validation department on project teams, providing validation assessments and contributing to the completion of projects. In brief my experience includes- Reviewing and approving validation protocols, validation plans, summary reports, risk assessments according to compliance with quality standards-Expertise validating in accordance with FDA Part 11, cGXP (GDP, GMP, GCP, GLP, GCP) guidelines- Reviewed validation deliverables to assure compliance with 21 CFR Parts 11 (Electronic Signatures & Records), 210, 211, 50, 56, 58, and FDA Regulations in the Software Development Life Cycle (SDLC) and checked the functionality of the system and executed scripts in validation environments by writing manual test scripts. Reviewed the scripts after formal Validation-Responsible for analyzing business requirements, development of validation plans (VP), Validation Protocols (Installation Qualification, Operational Qualification, and Performance Qualification), Requirement Traceability Matrix (RTM), Deviation reports, commissioning, and Decommissioning protocols, and Summary Reports (Validation and Test Summary Reports, VSR/TSR).I have a educational background in healthcare, with dual Master’s degree, first one in Master of Science in Health Informatics from Southern New Hampshire University and second one in Master of Business Administration in Health/Health Care Administration/Management. I have expertise in validating systems and equipment in accordance with FDA Part 11, cGXP guidelines, and Software Development Life Cycle. I have also experience in resolving deviations, CAPAs, and Root cause analysis techniques. Member of ISPE- Boston chapter.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.