NagendraWHO-AUDITOR

    Mr. Nagendra Kumar, who having 18 years and above work knowledge in R&D and Formulation Pharma industry in terms of Engineering and Quality Assurance activities.

    Vendor Qualification exposure for API & Formulation Industries. Independent handling of Site Quality Assurance activities for the past 6 years plus.

    Where associated with Dr.Reddy’s Labs, Gland Pharma, Hetero Drugs, Granules India, Appcure Labs (US based), Invagen Pharma (US) and also worked as a Vendor Audits consultant for few Pharma Industries (Formulation & API Plants) of inland as well as Overseas and his qualification back ground is M-Tech & MBA.

    SKILLS:

    – Good exposure in Facility Audits of all Dosage forms.

    – Exposure in Vendor Audits

    – Engineering Assurance Compliance w.r.to Process Equipment’s, Utilities, Calibration/Validation. PMP ,Procedures and Systems.

    – Good Exposure in QMS, Market complaints, Deviations, Change Control, Handling of Internal Audits,

    Handling of OOS & OOT…etc.

    -Handling of Training Programs.

    -Risk Assessment towards Process, Equipment’s and Software(GxP)

    -Process Validation, Cleaning Validation, Hold time Studies for Area/ Equipment, Product and Ultra- –

    Low- temperature Studies.

    –  Handling of Transportation Studies.

    – All sorts of Equipment, Product Validations, Software Validation, Method Development & Method Validation

    – Stability sample studies Program.

    – Handling of Recall Products

    – Handling of SMP and VMP programs for Equipment and Gxp approach

     

     PROFESSIONAL DEVELOPMENT:

    Actively participated in various audits: US-FDA, MCC, TGA, MHRA, ANVISA,EU  (In-Farmed/ Portugal) &TFD Inspection (Tanzania Food and drugs)

    Undergone NABL training of AN ISO/IEC 17025:2005 &AN ISO/IEC 17025:2015  for Laboratory Quality Management System & Internal Audits.

    1 day training conducted by International Auditor by Dr. van Zyl for QMS as per WHO Prequalification of Medicines Program.

    AUDITS EXPOSURE:

     He Conducted more than 50 plus Vendor Audits for API Plants, Formulations sites (CMS), Testing Laboratories for both Nation and International Exposure.

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