Chandana Chintala

Experience

1. Cqv Engineer

   博士伦

   Jun 2023 — Present · Tampa, FL, US

   Experience in developing and reviewing User Requirement Specifications (URS), Design Specifications (DS), Validation Protocols (IQ, OQ and PQ) and final reports.• Good knowledge on Federal Regulations 21 CFR Part 11(Electronic Records, Electronic Signatures, Audit Trails and Security events).• Involved in the qualification of equipment\'s for qualification studies and executed according to approved protocols and SOPs.• Performed temperature mapping using Kaye Validator system for environmental rooms and CTUs.• Involved in authoring and execution of IOQ and PQs of equipment such as autoclave and other CTU\'s.• Assisted in the qualifications for utilities such as WFI, HVAC systems and pure steam.Drafted and executed protocols for the qualification of autoclaves, ovens and incubators in accordance with Validation Master Plan.• Updated the Requirement Traceability Matrix (RTM) to reach out to the requirements at any time.• Communicated questionable and out-of-specification (OOS) results to supervisor, raised CAPA (Corrective Action & Preventive Action) report for results that are out-of-trend (OOT).

Education

• Chalapathi Institute of Pharmaceutical Sciences, Lam

  B. Pharmacy, Pharmaceutical sciences

• University of North Texas

  Master of Library & Information Science - MLIS, Health Informatics