Summary
Overview
Work History
Education
Skills
Instruments Used
Awards
Timeline
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ROHIT MISHRA

Guelph,ON

Summary

I love to dig into problems and solve them with scientific rationale. I focus on delivering key outcomes, building amazing teams and quickly adapting to new learnings. I have enjoyed every position throughout my career. Having wide experience of 11 (+) yrs. and presently working as Quality Scientist I

Overview

13
13
years of professional experience

Work History

Quality Control Scientist

Kenvue
06.2023 - Current
  • Evaluated components and raw material against quality standards and specifications.
  • Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
  • Developed and implemented inspection processes to define criteria and quality control measures.
  • Inspected quality of products, taking note of functionality, appearance and other specifications.

Quality Assurance - Senior Associate

Endo India Pvt. Ltd.
05.2021 - 04.2023
  • Root cause analysis using QMS tools
  • Investigation and review of Incident / OOS / OOT / EP
  • Review of CAPA / Change Control using Track-wise
  • Review of analytical document for Raw Material / Finish product / Stability Summary reports
  • Preparation of OOS summary reports, Preparation of QMS trend reports
  • Preparation of SOP's for the routine revision / implementation of procedures
  • Conducting monthly walkthroughs in QC to ensure compliance Review of audit trail verification report for Empower and all standalone instruments
  • Review of IQ / OQ and PQ of laboratory instruments, Conducting internal audits and support during regulatory audits

Quality Control - Senior Officer

Glenmark Pharmaceuticals Ltd.
05.2016 - 05.2021
  • Participation in out of specification investigations and the writing of analytical variances of lab error, Investigation of out of trend results and preparation of investigation reports, Investigation of laboratory errors / incidents / extraneous peaks and preparation of investigation reports, Preparation of the SOP'S for the routine revision / implementation of procedures, Preparation of the audit summary report and audit response, Processing of chromatographic data for quantitative test analysis performed in QC, Test analysis of formulated products i.e
  • Assay / Dissolution / Content Uniformity / Related Substances, Worked closely with QC lead / Manager as a team member following established test schedule

Quality Control - Senior Officer

Sun Pharmaceuticals Ltd.
06.2011 - 01.2016
  • Calibration of HPLC, GC, UV Spectrophotometer, Dissolution Apparatus, Infra-Red etc., Calibration of standalone instruments i.e
  • Disintegration Tester, Tap Density Apparatus, Viscometer etc., Preparation of reagents and standardisation of volumetric solutions, Installation, Performance and Operational qualification of various laboratory instruments, Re-qualification and supplementary qualification of various instruments, Assistance in the management of contract laboratories for external calibration, Upkeep of calibration and qualification program for laboratory equipments, Preparation and maintenance of monthly and annual instrument calibration planner, Train entry-level chemists on cGMP, standard operating procedure revision updates

Education

Bachelors in Pharmacy - Pharmaceutical Science

RGPV University, Bhopal (M.P) India
06.2011

Diploma in Pharmacy - Pharmaceutical Science

MIT College, Ujjain (M.P) India
04.2008

Skills

  • Strong QMS skills
  • Critical Thinking
  • Technical Writing
  • Strong analytical skills
  • Strong oral and writing skills
  • Ability to work in a challenging and fast-paced environment
  • Creative / problem-solving
  • Versed in guidelines / regulatory requirements
  • Quality-oriented
  • GMP-oriented

Instruments Used

  • HPLC (Make Waters, Software Empower 3)
  • GC (Make Perkin Elmer & Agilent)
  • Differential scanning calorimetric (Make - Perkin Elmer)
  • Thermo gravimetric analysis (Make - Mettler Toledo)
  • UV-Spectrophotometer (Make Shimadzu and Perkin Elmer)
  • Infrared-Spectrophotometer (Make - Perkin Elmer)
  • Dissolution testing Apparatus (Make Electro lab & Distek)

Awards

  • Received spot award for error-free analysis 3 times in a row
  • Received 5-star rating in annual assessment for error-free analysis and contributing in achieving TAT (FY: 2016)
  • Received 5-star rating in annual assessment for error-free chromatography throughout the year (FY: 2018)
  • Received Gold tier award twice in a row for president club annual assessment organized by Glenmark Pharmaceuticals Ltd. (FY: 2018-2019)

Timeline

Quality Control Scientist

Kenvue
06.2023 - Current

Quality Assurance - Senior Associate

Endo India Pvt. Ltd.
05.2021 - 04.2023

Quality Control - Senior Officer

Glenmark Pharmaceuticals Ltd.
05.2016 - 05.2021

Quality Control - Senior Officer

Sun Pharmaceuticals Ltd.
06.2011 - 01.2016

Bachelors in Pharmacy - Pharmaceutical Science

RGPV University, Bhopal (M.P) India

Diploma in Pharmacy - Pharmaceutical Science

MIT College, Ujjain (M.P) India

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