Vinayak Mhatre

Experience

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  Self Employed

  Nov 2014 - now

  Professional Freelancer

  Expertise in Overall QC functions and QA-QMS investigations. Worked at plant as well as corporate levels in QC and QA functions for about 23 years. Have worked in QC and QA departments of API as well as formulations units. Certified Trainer and Auditor for Pharmaceutical GMP and GLP from Insight Systems, Pune, India. Actively working as freelance consultant in these areas since 2014. Provided technical consultancy and Training at about 15 to 20 Indian Pharmaceutical companies (API & Formulations). Training conducted on the topics like OOS, Data Integrity, Laboratory errors reduction, Stability, Deviation, Change control, Investigation review, Grooming of technical staff, Analytical techniques like HPLC, GC, UV. FTIR, KF, Auto-titrators, etc., GMP, GLP, GDP, Laboratory Incidents, etc.Technical consultancy includes gap analysis in overall Quality systems followed by remediation plan, Analytical data review, Stability review, Audits of manufacturing and testing facilities, OOS and other QA-QMS records review, etc. Show less