Prathap Gonela Email & Phone Number

Meticulous and skilled professional with impressive experience in the Pharmaceutical Quality vertical. Currently I am working with CAI, Ireland. My present role serves as Validation Engineer for the Pharmaceutical clients which includes CSV, CQV and Quality functions. I associated with Accenture limited as Associate Manager in the Life sciences domain. I were responsible for the validation related documentation such as GxP Risk Assessment, Validation Plan and summary authoring and review of mandatory documents in the CSV life-cycle. My role includes the overview of Compliance in the project. Collaboration with the clients for smooth functioning of the documentation activity as well as Validation progress in the project. I have extensive knowledge on the regulatory guidelines and GAMP practices. I have got well acquainted with Good Laboratory Practice (GLP), Good documentation Practices (GDP), Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice-Verification & Validation model. My functional forte also comprises working in QMS, performing laboratory investigations & GAP Analysis, documenting the remediation plan and reviewing/validating computer systems (CSV) as per 21 CFR part 11 & FDA regulations. My proven capabilities are optimizing processes & procedures to establish robust top Quality Management Systems (QMS) and applying various quality measures to ensure operational excellence.Previously, I had associated with Jubilant Generics Limited, Mysore, India as an Assistant Manager – QA. Wherein, I was responsible for internal audits, review and approval the analytical documents received from the QC department prior to batch release, performing root cause analysis, out of specification (OOS)/Out of Trend (OOT), Change management, deviations and laboratory incidents to establish CAPA processes through track wise application. During my tenure with the company,

Listed skills include Chromatography, Uv, Chemistry, Hplc, and 16 others.