Rakesh Gorantla Dqa

Background

About Rakesh Gorantla Dqa

RESUMEG.RakeshMobile: 9949163797E-mail: rakesh.gorintla@gmail.com Professional Profile Working as DQA (R&D) Manager in Aurobindo Pharma Limited in Hyderabad. From Jan 2019 to till date.Worked as CQA (R&D and Plant)(Analytical Review, Audit & complains, and GLP,) Deputy Manager in Mylan Labs Limited. From Jan 2012 to December 2018.Worked as a Sr.Executive (Centralized Stability Department) in Dr. Reddys Laboratories Ltd, Unit-II, and Bachupally from Nov 2009 to Dec 2011.Worked as a officer in Hetero Drugs Limited (EOU Block) from 2008 to Nov 2009.Present Job Responsibility in Aurobindo Pharma LimitedTotal charge of Quality Assurance activities of FARD Review of Verification and Validation protocols, reports and related raw data.Review of Change controls as per regulatory requirements.Review of Instrument Calibration reports and maintain the schedule of master calibration and Master preventive schedule.Review of laboratory Incidents and DeviationsAnalyst qualification record maintenance.Evaluation the training needs of personnel with respect to GLP and SOPs.Manpower training records. Provide Training to new employees and periodic training of employees and maintaining its record. Issuance of various Documents such as Instrument Log Books, Registers, Annexures and Formats etc.Periodic review of various lists such as Employee list, Instrument list, organogram.Review of GDP/GMP/GLP activities.Monitoring and checking instrument log books.Preparation of Guidelines, GTPs and SOPsMaintenance of Sop list, Guideline list, and GTPs.previous Job ResponsibilitiesReview of Audit trails of all instruments.Laboratory Information Management System (LIMS) review (Initiation, allotment, Review and Release).Review and preparation of Validation Reports and Protocols.Review and preparation of Method Transfer Reports and ProtocolsReview of Pre-formulation data and product development Reports.Responsibility of internal audits (CFT member).Review of compilation of stability data and Protocols.(Before submitting to customers)Investigation and Review of OOS and OOTReview of analytical Reports (Supporting raw data, Development data, Finished Product, Stability, Raw material)Review and Preparing of Impact Assessment Reports and Investigation Reports.