Summary
Overview
Work History
Education
Skills
Accomplishments
Industry Exposure
Software And Tools
Family
Total Years Of Experience
Timeline
AssistantManager

Nagendra Kumar Gupta C V

Assistant Manager
Hyderabad

Summary

Experienced Senior Research Scientist in Analytical Research and Development with 13 years of expertise in Analytical research and development and Analytical Assurance. Skilled in various dosage forms such as Injections, Ophthalmics, and Inhalations. Seeking a challenging position to further expand knowledge and skills in a reputable organization.

Overview

14
14
years of professional experience
2011
2011
years of post-secondary education
2
2
Languages

Work History

Assistant Manager

Orbicular Pharmaceutical Technologies Pvt. Ltd
12.2017 - Current
  • Review OOS investigations, CAPAs, Change controls and all other related activities.
  • Assist in root cause analysis for Out of Specifications investigations, customer complaints.
  • Liaise with customer to ensure customer requirements are satisfied.
  • Ensure compliance with SOPs, policies and procedures as required by company and regulatory agencies.
  • Review of Analytical method development reports, Method validation, method transfer protocols and reports.
  • Review of Elemental impurities and Nitrosamines risk assessment and/or validation protocols & reports.
  • Review of Extractable and Leachable protocols and reports.
  • Review of Drug Master File (DMF).
  • Review of Justification for specification, Study protocols and reports.
  • Review of Specification and Standard Test Procedure.

Strides Shasun Ltd
12.2016 - 12.2017
  • Responsible for verification of audit trails of Instruments.
  • Review and approve the calibration, qualification and preventive maintenance records of instrument and equipment’s.
  • Timely investigate out of specification/out of trend and aberrant events (Incidents and deviations) reported in laboratory and suggest suitable CAPA.
  • Review and approve working standard qualification records.
  • Review and approve analyst qualification records.
  • Ensure laboratory and documentation are up-to-date and ready to face audit at any time.

Dr. Reddy’s Laboratories Ltd
01.2014 - 11.2016
  • Development of improved analytical methods for the existing products.
  • Method transfer to the different labs (both internal and external).
  • Pharmacopeial Methods implementation.
  • Analytical support for the commercial products.
  • Stability data monitoring and closure of OOS and OOT.

Leiutis Pharmaceuticals Pvt. Ltd
12.2011 - 12.2013
  • Method development.
  • Compatibility studies.
  • Lab scale batch stability studies.
  • Method validation.
  • Dilution studies.

Education

M. Pharmacy - Pharmaceutical Analysis & Quality Assurance

Raghavendra Institute of Pharmaceutical Education & research

B. Pharmacy - undefined

Raghavendra Institute of Pharmaceutical Education & research

+12 (XII) - undefined

ABHYAS

SSC (X) - undefined

SSMH

Skills

Method Development

Accomplishments

GATE-2009 qualified (Rank – 1243)

Industry Exposure

  • Analytical Research & Development
  • Analytical Assurance
  • Commercial Analytical problem solving
  • Stability Testing
  • Audit & Compliance

Software And Tools

  • EMPOWER
  • CHROMELEON
  • MS EXCEL
  • MS POWER POINT

Family

C V S Rao, Rtd. Lecturer – Economics, Savithri, Naga Madhuri, Naga Eshan Madhav (1st Std)

Total Years Of Experience

13

Timeline

Assistant Manager

Orbicular Pharmaceutical Technologies Pvt. Ltd
12.2017 - Current

Strides Shasun Ltd
12.2016 - 12.2017

Dr. Reddy’s Laboratories Ltd
01.2014 - 11.2016

Leiutis Pharmaceuticals Pvt. Ltd
12.2011 - 12.2013

B. Pharmacy - undefined

Raghavendra Institute of Pharmaceutical Education & research

+12 (XII) - undefined

ABHYAS

SSC (X) - undefined

SSMH

M. Pharmacy - Pharmaceutical Analysis & Quality Assurance

Raghavendra Institute of Pharmaceutical Education & research

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Nagendra Kumar Gupta C VAssistant Manager