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