Dr Ragavendran P

Experience

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  CARe Keralam LTD

  Jan 2013 - Mar 2014

  Analytical Biochemist

  Authenticated person for the equipments named as LCMS, ICPMS, GCMS, HPLC, HPTLC. To perform validation, Instrument calibration, New method development, trouble shooting and perventive maintanence. To perform the Measurement Uncertainty calculations.

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  SKS Hospital Laboratory (in association with SKS Hospital)

  Jun 2014 - Dec 2017

  HOD Biochemistry & Asst Quality Manager

  Managing laboratory operations involving preparation of equipment, products and materials for experiments & surveys and developing new methods and equipment Monitoring the MIS report of Laboratory for smooth operations Supervisingequipment performance evaluation, quality procedures (IQC, EQA, ILQA), method validation and measurement uncertainty calculation to conduct analysis in Biochemistry, Immunology &Hematology Preparing specification SOPs and relevant documents; undertaking analytical method validation & related documents Maintaining the documentation of in-house analytical methods developed and standard testing procedures and specifications for routine use by QC personnel Planning and conducting Internal Audit apart from Management Review Meeting Monthly process evaluation of Physician feedback Show less

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  Neuberg Diagnostics

  Jan 2018 - Nov 2018

  Quality Assurance Manager

  • Developing & implementing the strategies for the Quality Department to ensure that it meets the business requirements; managing customer deliverables and accreditations PAN Tamil Nadu• Preparing Technical and Management System Report, Quality-MIS, Medical Ethics; managing Feedback & CRM• Monitoring Performance Evaluation of Medical Devices as per CLSI guidelines, ISO 15189, QA systems in standalone lab & hospital based labs and Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements• Managing the development of SOP (Written, Revision & Approval); ensuring that the regulatory compliance are in conjunction with being fit for purpose operationally & commercially• Ensuring that all the activities are performed in accordance with GLP includingpolicies for all technical & non-technical aspects, audit program is well communicated to the operations team & the supplier and subcontractor audits are performed & reported as per the scheduled Show less

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  HCL Technologies Ltd

  Nov 2018 - Jul 2021

  Technical Lead in Regulatory Affairs

  • Analytical and Clinical validation of In-vitro diagnostics (IVD) devices as per CLSI standards and IVDR_2017-746.• Protocol and test procedure preparation as per CLSI/ISO standards.• Evaluate Clinical Performance of IVD Reagents, Control and Calibrators as per CLSI & ISO Standrads and Review of IVD products as per regulations & ensure that quality standards are met and submissions meet regulatory guidelines.• Troubleshoot as appropriate for successful execution with team and Improve delivery efficiency and Quality output of project management.• Develop and maintain the Quality Management system and supporting procedures capable of meeting ISO 13485, EU IVDR 2017_746.• Reviewed based on European regulation.• Handle team with various assessments.• Led Customer and Regulatory Audits / InspectionAchievements• Installed Lab in Velammal Medical College for Execution of Clinical Evaluation of IVD Reagents – Dry chemistry Device, Electrolyte Device, Osmolality Device and HbA1c devices for Japanese Client (ARKRAY Inc). Show less

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  Agilus Diagnostics

  Jul 2021 - May 2022

  Lab Manager - SRL Diagnostics

  • To support Section Managers in planning/organizing an effective manpower utilization within their respective sections.• To support all sections in implementation of the profit improvement plans the Development & Monitoring of resources.• To verify that all sections enter the consumptions in the WIP on a weekly/fortnightly basis and monitor the recipe v/s consumptions variance across all sections.• To support Section Managers & enable them to reduce the Reassay % for their respective sections & analyze the monthly statistics of all sections.• To monitor QA issues & ensure implementation of corrective actions from all sections and New test code generation for all new tests launched and interface on day to day issues with Materials, Engineering, IT & Lab.• Extending customer care support & resolutions to all International clients for test queries/report status/logistics information VIA email & telephone, Daily resolving & monitoring the follow-ups of all problem samples on arrival at accession dept, Frequent interfacing with all Lab sections for test availability/test codes, on receipt of tenders/ proposals/ various countries price list.• Conducting Lab visits for Domestic clients. Show less

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  Poct service pvt ltd

  Jun 2022 - now

  Laboratory Operations Manager

  • To define new devices based on test load and ensure installation of all the new equipment’s and proper IQ, OQ & PQ and other documents are filled. • Review and Monitoring of MIS – Technical & Quality, Risk Management Analysis. • Dashboard Analysis of Cost Benefit on Periodic Intervals and Calculate EBIDTA analysis for reducing operational cost. • Evaluate External Lab for ILC and outsource testings. • Validation for all the new assays is carried out, prepare documents for Internal Audits & External Audits, Technical Sop’s and other function Sop’s are in place & regular training on Pre-analytical, Analytical & Post Analytical for all the lab staff’s.• To ensure swift resolution of CCG queries from various sections. • Validate Reagents from Manufacturers and device as per National and Local bodies Regulatory requirements and prepare data analysis with software.• Responsible to ensure clinical research studies are conducted in compliance with GCP/ICH and local applicable regulations• Ensure Inventory Management, Device document Maintanence, New parameter & New device implementation, Conduct training of staff members and Client interaction.• Maintain the Quality Indicator and Quality development based on 5S and Six sigma.• Communicates with clients during the setup and performance of a test to demonstrate equipment test methods and/or to discuss test results• Responsible for Lab accreditations such as NABL, NABH and other regulations.• Recruited and conducted an orientation program of new employees• Validated the new release of Laboratory Information SoftwareAchievements• Resulting in 20% of Operational Cost saving of Control & Reagent Utilization Show less