Ravi Kumar

Experience

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  AUROBINDO PHARMA LTD

  Oct 2006 - Feb 2008

  QC finished api analyst

  Conduct complete analysis as per the established STP’s and with cGMP requirements for the finished products.Residual Solvent analysis of finished products to confirm by using GC and HSGCTech transfer of the analytical methods / trouble shooting on transferred analytical methods. Conduct analytical instruments calibration against Compendia requirements.Compliance of cGMP and established practices. Stability studies of various finished products at ambient conditions and at accelerated conditions. Show less

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  Orchid Pharma

  Feb 2008 - May 2013

  Research Associate

  Harmonizing heavy metal analysis and metal analysis for drug substance and drug products produced in different locations of the organization.Conduct analytical method development and Validations as per the established practices and with ICH requirements for genotoxic impurities, degradation products and Residual Solvent. Developing LCMS compatible HPLC methods for API and its related impurities. Optimizing Stability indicating method for API (Forced degradation study).Analytical method evaluation as per the pharmacopoeia methods of API.Tech transfer of the analytical methods / trouble shooting on transferred analytical methods.Compliance of GLP and established practices. Preparation of SOP’s as per GLP Practices. Method equivalent study of compendia and non compendia methods. Conduct stability study as per ICH and compilation of Stability data.Qualification of Working standards, impurity standards, intermediates and raw materials. Show less

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  AstraZeneca

  Jun 2013 - May 2014

  Research Scientist

  Manage analytical requirements for project delivery. Leading analytical project team to communicate and share the analytical status to European counterparts.Holding instrument ownership to manage preventive maintenance, control of spares and calibration of instruments for enhancing productivity and efficiency. Investigating OOS and OOTs. Setting up in-process control criteria for chemical reactions, specification for raw materials intermediates, contributory raw materials and drug substances. Ensuring GMP compliance on all quality attributes by maintaining appropriate requisite documentation/records with the help of GEL, ELN, ADMS, ATLAS, DSA, AZLearn, EMpower and OCM.Finding the product nature of Drug substance by using DVS instrument.Technical stewardship support for the life cycle projects which is patented for AstraZeneca Show less

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  Hospira

  Jun 2014 - Aug 2015

  Assistant Manager in Technology transfer

  Method development, validation of method for elemental impurities by using AAS and ICPMS.Method feasibility studies to identify the challenges of the method as a part of life cycle management.Remediation of analytical methods by using instruments like HPCL, UPLC, GC, HSGC, AAS and ICPMS.Remediation validation for analytical method to bring the methods to current regulatory requirements.Involving in manufacturing investigations as an SME for analytical evaluations.Identifying the unknown impurities by using HSGCMS and HRMS and support for isolation and characterization of the impurities and SAR studies for establishing the toxicity of the impurities. Show less

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  Pfizer

  Sept 2015 - Sept 2019

  Leading Material characterization, Extractables & Leachables and Impurity isolation and characterization team. Setup a new lab for Material identification and characterization/forensic investigations with the advanced instruments like Stereo microscope, Polarized light microscope, Digital microscope, Inverted light microscope, Scanning electron microscope with EDS capability, FTIR with microscope and SPE with LIBS and Raman spectroscopy.Established team to conduct Extractables and Leachables team to support the manufacturing sites.Established new team according to business requirement for impurity isolation and characterization to support ongoing IKKT method remediation validation and transfers.SME for Elemental impurities method development, validation and transfer by using AAS & ICP-MS.Lead for remediation validations, method remediation’s, cleaning method development, validation and transfer to manufacturing sites (Vizag, Rocky Mount, Lake Forest and McPherson)Certified green belt investigator by Pfizer to conduct DMAIC investigations. Maintain the lab compliance through Change managements, Events, QAR, NTM, CAPA, LIR through QTS and maintaining the QMS compliance for the labHaving experience in USFDA, MHRA, TGA, Health Canada and internal corporate audits.Implementation eLN to GTS colleagues. Train the colleagues for Yellow belt investigations. Show less

  • Manager

    Apr 2017 - Sept 2019

  • Deputy Manager

    Sept 2015 - Mar 2017
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  Sandoz

  Sept 2019 - now

  Principal Scientist