Summary
Overview
Work History
Education
Skills
Accomplishments
Instrument Handled & Expertise
Personal Information
Timeline
Generic

Lokendra Kumar

Bijnor

Summary

To pursue a challenging position to meet the challenges of a dynamic and demanding market/work environment, which will enable me to put my professional education and functional talents to achieve results for the organization, which will give me professional satisfaction and career growth.

Dynamic, result oriented technical professional with rich cross functional experience in effective Management of entire domain of Quality Control functions. Responsible, Reliable, Self-motivated, professional having excellent capability of Quality Control Functions.

Overview

11
11
years of professional experience

Work History

Executive

MANKIND PHARMA LTD. UNIT-III
07.2019 - Current
  • Highly skilled and detail-oriented Quality Control Specialist with over [10] years of experience in analysis of raw material, Stability samples and finished products samples
  • Worked as a team leader in stability section
  • Currently involved in investigating and resolving Out of Specification (OOS) and Out of Trend (OOT) results with scientific approach for finding root cause and implementation of CAPA

Senior Officer

AKORN INDIA PVT. LTD.
11.2017 - 07.2019

QC Officer

MANKIND PHARMA LTD. UNIT-I
07.2016 - 11.2017

QC Officer

SALUD CARE INDIA PVT. LTD.
07.2014 - 06.2016

Education

M.Sc. - Industrial Chemistry

RSM PG College of MJPR University
06-2013

B.Sc. - Industrial Chemistry

RSM PG College of MJPR University
06-2010

Skills

  • OOS/OOT Investigation and Resolution
  • Root Cause Analysis
  • GMP, GLP Compliance
  • Data Integrity and Documentation
  • CAPA Management
  • Statistical Analysis and Trend Analysis
  • Data review
  • EWMS & S4HANA
  • Caliber LIMS
  • Analysis of Inprocess & Finish product
  • Team Leader

Accomplishments

  • Successfully resolved OOS/OOT investigations, preventing potential production delays and improving product quality.
  • Reduced investigation cycle time by [X]% by streamlining documentation processes and improving cross-departmental communication.
  • Draft clear, concise, and well-documented investigation reports.
  • Trained and mentored junior staff on investigation techniques and compliance requirements.
  • Worked as a team lead in stability section.
  • Regulatory agency audit faced like- USFDA, MHRA, EU, PIC/S(Malaysia), WHO, Nigeria, Ukraine, Uganda & Customer’s.

Instrument Handled & Expertise

  • Handling & Investigation of LEIR/ Incident / OOT / OOS / Deviation/change control and CAPA (implementation & Effectiveness) - In Caliber QAMS.
  • H.P.L.C. [Waters, Shimadzu & Agilent]
  • G.C. [Agilent]
  • Dissolution [Electrolab, Lab India, Distek]
  • UV-Vis Spectrophotometer [Shimadzu]
  • Disintegration Tester [Electrolab, LabIndia]
  • Friability Apparatus [Electrolab, LabIndia]
  • Karl fisher Titrator [Electrolab]

Personal Information

  • Total Experience: 10 Years
  • Father's Name: Mr. Digvijay Singh
  • Date of Birth: 01/01/91
  • Gender: Male
  • Marital Status: Married

Timeline

Executive

MANKIND PHARMA LTD. UNIT-III
07.2019 - Current

Senior Officer

AKORN INDIA PVT. LTD.
11.2017 - 07.2019

QC Officer

MANKIND PHARMA LTD. UNIT-I
07.2016 - 11.2017

QC Officer

SALUD CARE INDIA PVT. LTD.
07.2014 - 06.2016

M.Sc. - Industrial Chemistry

RSM PG College of MJPR University

B.Sc. - Industrial Chemistry

RSM PG College of MJPR University
Lokendra Kumar