Uru Patel Email & Phone Number

Active team member for Product development of Medical Devices (Hormonal intrauterine System, Surgical Sutures, Mechanical Closure devices). Analytical Method development, Validation, Continuous Quality improvement , Documentation, Equipment Calibration, Audit Compliance.Document Change Control, Quality Management SystemQuality Assurance, issuance of Batch record, retrievalPreparation & Review of Analytical Reports, Experiment reports, plant trial, Stability Study as per guidelineSAPAnalysis of - RM, Intermediate & Finished Product.Controlled sample (retention Sample) maintenance

• 

  Quality Executive

  Meril Endo Surgery Private Limited

  Oct 2013 - Feb 2019 - Vapi

  JOB PROFILE:To perform Quality Control testing of Raw Material, Packing Material, In-process & Finished Product. To maintain on-going shelf life study program and prepare new shelf life program for new introduced products including maintaining the supporting data (Reports, Protocol, raw data sheets) To Prepare & edit new technical Specification, Standard Operating Procedure, Standard testing procedure,artworks, Validation Protocol as well as report for all products. To Control the documents/Artworks for all products for Quality Control & Quality Assurance as per QMS. To assist quality assurance Manager to provide necessary documents to regulatory team for Product Registration. To record and maintain all data pertaining to quality control testing. To make recommendations for improved productivity and quality. To perform additional duties as required. To perform all duties in accordance with established safety guidelines. To assist Quality Assurance Manager with necessary evidences and other technical support for internal & external quality Audit compliance. Secondary point of contact for Division auditors. To maintain necessary data like calibration matrix, annual calibration review, calibration planner etc. for equipments to be calibrated by outside service provider/ Agency as well as to perform In-house Calibration of QC equipments if required. To monitor & inform reporting head about the non-conformance regarding Incoming, in-Process and FG Stage & Rectify the same with the help of Reporting Head. To assist Quality Assurance Manager with product and process evaluation. Maintaining Record regarding Retention samples, its usage & destruction • To Train & evaluate employees for various documents & procedures.

• 

  Sardar Patel University, Vallabh Vidyanagar

  Clinical Laboratory Science/Medical Technology/Technologist