Bharath Shetty Email and Phone Number
Achievement driven Quality Professional with 6 years of experience seeking Opportunity in CSV Quality Assurance and Compliance with a growth oriented organization. Knowledge on V-model of validation for GxP Projects for Life science pharmaceutical and healthcare industry. Developing, Reviewing, Validating, and Monitoring of Test scripts, Test plans, and Test cases based on URS from clients. Expertise in Preparation of Validation Plan and protocol, Validation Report, RTM and SOP writing and revision. Abilities in Data management and validating various quality documents using software in pharmaceutical companies. Responsible for Testing and verification of Validation for Laboratory instruments on GAMP guidelines. Exposure to GxP, GAMP, USFDA, EU guidelines, 21CFR Part 11, EU Annexure 11 for Pharmaceuticals and Software as medical Devices industry.
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Sr Software EnggWipro Nov 2024 - PresentBengaluru, Karnataka, India -
Validation EngineerJoulestowatts Business Solutions Pvt Ltd Apr 2024 - Nov 2024Bengaluru, Karnataka, IndiaWorking for Wipro(Bayer Healthcare account) as a Validation Engineer, handling their life cycle management tools such as Jira, RQM, JFrog Platform. -
Sr. ExecutiveSyngene International Limited Sep 2021 - Mar 2024Bengaluru, Karnataka, India- Preparation and Review of documentation likeProtocols, Test Plans, Test scripts, and Reportsassociated with Computerized systems. (Deliverableslike URS, GxP, ER/ES assessment, VP, FS, CS, IQ, OQ,PQ, and RTM documents.)-Qualification of equipment along with application (CSV)in line with 21 CFR Part 11, GAMP5, ICH Q9 followed byEU Annex II.-Good Knowledge of CFR Part 11, EU Annex 11,-Good Knowledge of V-Model and Agile ModelFramework projects.-Strong understanding of SDLC and CSV methodologies.-Driving of Change controls, CAPA, and Effectivenesscheck of CAPA.-Good knowledge of the Pharmaceutical LaboratoryProcedures, Regulatory Guidelines, Compliance andModules.-Review of Vendor/Supplier Assessment documents.-Review Analytical documents likeValidation/Calibrations/Qualifications protocols andReports.- Ensuring Laboratory compliance with StandardProcedures. -
AssociateMylan Jun 2019 - May 2021Bangalore-CSV and compliance activities. -Driving of Change controls, CAPA and Effectiveness check of CAPA. -Periodic review of software applications -
Analytical Research AssociateThe Himalaya Drug Company Dec 2017 - May 2019Bangalore
Bharath Shetty Education Details
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Chemistry -
Poorna Prajna College, UdupiChemistry -
Poorna Prajna College, UdupiChemistry
Frequently Asked Questions about Bharath Shetty
What company does Bharath Shetty work for?
Bharath Shetty works for Wipro
What is Bharath Shetty's role at the current company?
Bharath Shetty's current role is Computer System Validation | Quality Assurance |Power BI.
What schools did Bharath Shetty attend?
Bharath Shetty attended Manipal University, Poorna Prajna College, Udupi, Poorna Prajna College, Udupi.
Who are Bharath Shetty's colleagues?
Bharath Shetty's colleagues are Sumit Gurav, Sarosh Siddiqui, Subhashree Patra, Yaklur Shaik Farhana Nusreth, Vivek Anandan, Vinodkumar Vc, Subarna Habib Sarkar.
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bharath shetty
Having 4+ Years Of Experience In Oracle Dba With Area Of Practice Oracle In 9I, 10G, 11G, 12C And 19C Environments And Rac.Hyderabad -
Bharath Shetty
Bengaluru
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