Experience

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  Everlife-cpc diagnostics

  Jun 2019 - Jul 2021

  Senior assistant - quality control

  ● In-house testing of Clinical biochemistry, Immunoturbidimetric andHematology reagents.● Performing various stability studies of Bulk reagents manufactured(Accelerated , Onboard , Calibration, Open vial , Sterility and Real timestability studies)● R&D analysis and interpretation.● Key role in ISO 13485 audit and Internal auditing at the Manufacturingunit.● EQAS testing , Conductivity and pH monitoring.● Raw materials testing.● Analysis of finished products and release.● Post market surveillance and new product evaluation.● Review of market complaints and customer feedback for field safetycorrective actions and root cause analysis.● SOP revision, NC, CAPA & COA Preparation and Physical inspection of Finished products before release. Show less

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  Randox

  Jul 2021 - Jan 2023

  Officer qa & qc

  ● Act as Deputy Management Representative.● Responsible for handling and effective operation of the QMS, based on ISO 13485:2016● Competent Technical staff for Testing (Approved by the Drugs Control department Karnataka) ● cGMP/ GLP compliance, scheduling internal quality audits, BMRpreparation and review , Site Master file, Quality Manual,COA’s/MSDS.● SOP review and revisions, validation protocols, raw data review inoperations, Implementing PCA, Non-conforming process, CAPAinitiation and close-out, SCAR, GAP analysis, Risk assessment &Management based on ISO 14971:2019● Participate in Supplier/ vendor qualification audits.● Maintaining International ( CE mark- as per European medical devicedirective and EU IVDR) Technical file & National Regulatory Affairs.●Manufacturing License(State & CDSCO) and Import License as per MDR (CDSCO) , Pollution control Board, Market standing & Non conviction certificates, Mandatory registration on non regulated devices in India. ● Preparation of Device Master File and handling of Q-Pulse software.● Create, implement, maintain and enhance QC test plans and testmethodologies that ensure exhaustive testing of all assignedsystems to ensure compliance with manufacturing specifications.● Maintenance and documentation of all quality related records.● Conduct Induction Training on QA process and activities. Show less

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  Danaher corporation

  Jan 2023 - now

  Quality assurance specialist