Nitin Kumar Tyagi Email & Phone Number

M.Sc.(Organic Chemistry) and PG diploma in PQAQC with more than 18 years experience in Pharma Quality Assurance Deptt.“Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for. A product is not quality because it is hard to make and costs a lot of money, as manufacturers typically believe. This is incompetence. Customers pay only for what is of use to them and gives them value. Nothing else constitutes quality.”Specialties:  Process Validation  Execution of Technology Transfer of Process Responsible for ensuring cGMP compliance of audit observations.Quality concept documentation as per cGMP norms.SOP Documentation in EDMS.Regulatory Affairs communication and Document provide to RA for DMF submission.Audits:MHRA(2007)USFDA(2009)USFDA(2011)USFDA (2015)USFDA (2018)WHO(2011)WHO(2014)WHO(2018)TGA(2012 & 2017)

Listed skills include Quality Assurance, Change Control, 21 Cfr Part 11, Technology Transfer, and 8 others.

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  Chaudhary Charan Singh University

  Organic Chemistry