Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Disclaimer
Languages
Audit Experience
Activities
Timeline
Generic
Prasoon Mishra

Prasoon Mishra

Indore

Summary

Dynamic Senior Research Associate with extensive experience at Endo-India Par formulation, excelling in method validation and analytical testing. Proven ability to solve complex issues and enhance team productivity through effective communication and collaboration. Skilled in instrument HPLC, IC, KF Coulometer, with oven, etc. operation, I consistently deliver high-quality results while maintaining rigorous quality control standards.

Overview

12
12
years of professional experience

Work History

Senior Research Associate

Endo-India Par formulation
Indore
07.2022 - Current
  • Analyzed experimental data to support formulation development and regulatory submissions.
  • Prepared detailed reports documenting research findings and methodologies.
  • Maintained detailed records of experimental protocols and data in laboratory notebooks.
  • Presented research results at internal meetings to foster knowledge sharing among teams.
  • Identified potential threats to properly manage project risks.
  • Discussed prerequisites to maintain team productivity for project goals and objectives.
  • Designed experiments based on hypothesis testing approach to validate scientific theories or principles.
  • Collaborated with colleagues from different departments i.e Quality assurance, warehouse, Quality Control etc. to complete the project within timeline with smooth processes.
  • Maintained accurate records of all laboratory activities including experiment results, observations.

Executive

Mankind Pharmaceutical Ltd.
Ponta Sahaib
10.2021 - 07.2022
  • Collaborated with senior leadership to drive corporate strategy and decision-making processes.
  • In quality control, the section tests and analyzes all test parameters, i.e. Assay, BU, CU, ASTM, RS, CP: Preservative content and data report completion to end of analysis.
  • Conducted drug analyses using advanced laboratory equipment and techniques.
  • Trained a junior analyst on laboratory protocols and best practices.
  • Assisted in troubleshooting equipment issues to minimize downtime in the lab.
  • Operated sophisticated analytical instruments such as high-performance liquid chromatography (HPLC), ion chromatography, coulometer with oven processor (water content test by gas vapor), UV-Visible, IR, density meter, Disintegration (DT), UV-Cabinet for Thin Layer Chromatography (Aetron software), etc.

Executive

Alembic Pharmaceutical Ltd.
Vadodara
07.2019 - 09.2021
  • Worked on the ophthalmic solution (eye drop), injectable complete study, i.e., method validation, verification, and tech. Transfer.
  • Analyzed validation, verification, and transfer protocols for analytical testing.
  • Trained junior analysts on best practices in validation techniques and methodologies.
  • Ensured that all validation processes were compliant with applicable regulations.
  • Collaborated with cross-functional teams to resolve quality issues.

Officer

Macleods Pharmaceutical Ltd.
Daman
11.2017 - 07.2019
  • Conducted quality control tests on drug substances and drug products.
  • Analytical method validation involves performing all parameters of validation, verification, and tech transfer of drug substances/products (API and tablets).
  • HPLC (Agilent, Waters (Empower software), Shimadzu CHT/AHT, Chromeleon software), Ion Chromatography (IC) (Chromeleon software), Ion Chromatography (IC).
  • Analyzed samples submitted for testing and reported results.
  • Trained a new trainee on quality control methods and safety protocols.

Management Staff

CIPLA Pharmaceutical
Indore
06.2015 - 10.2017
  • In Cipla, I worked as an analyst in the QC-Finished Product section, where I analyze drug substances like tablets, capsules, effervescent tablets, Multihaller (related substances, assay, content uniformity, B.U., and sample), and their physical analysis, handling OOS or OOT investigation incidents.
  • Maintained up-to-date knowledge of industry standards related to Quality Control practices.
  • Tested lab solutions, sampled finished materials, and cleaned sample tests for quality.
  • Maintained laboratory equipment in accordance with safety standards.
  • Identified and resolved problems with QC instrumentation.

Senior Officer

Ranbaxy Laboratory Ltd.
Dewas
07.2013 - 06.2015
  • At Ranbaxy Laboratory, I worked in the sterile production API department, handling autoclaves (steam sterilizers), dry heat sterilizers, crystallizers, ANFD, reactors, and RO.
  • I also validated all these instruments and performed pre- and post-calibration by Kay validator.
  • Charging batch, i.e., Meropenem, Imipenem, Cilastatin sodium, sterile.
  • Maintained accurate records of batch production records (BPR) of all batches used in production.

Education

Master of Science - Industrial Chemistry

Aligarh Muslim University A.M.U
Aligarh, U.P, India
01.2013

Bachelor of Science - Chemistry & Industrial Chemistry

V.B.S Purvanchal University
Jaunpur, U.P, India
01.2011

XIIth - Science

Maa Durga Ji Sr. Sc. Vidyalaya
Jaunpur, U.P, India
01.2008

Xth - Science

Maa Durga Ji Sr. Sc. Vidyalaya
Jaunpur, U.P, India
01.2006

Skills

  • Work with Discipline and responsibility as dynamic team player
  • Good communication skills, confidence, self-motivation, positive attitude, and a cooperative attitude
  • Ability as senior analyst to solve and find out root cause of incidence, OOS, OOT etc
  • Method validation
  • HPLC operation
  • Laboratory maintenance
  • Analytical testing
  • Experimental design
  • Quality control
  • Problem solving

Accomplishments

  • Selected in All India Aligarh Muslim University (AMU) Entrance Exams under 25th seat.
  • One Month Training in CG&CRI Lab Of CSIR, Khurja Bulendsehar, Under supervision of Sr. Scientist D.P Karmakar.
  • Awarded Certificate of International Conference 3rd Science Conclave as Noble Leautrates (MHRD-DSA) IIIT Allahabad, U.P India.
  • Awarded by 'Above and Beyond' and Good Job with Thank you card during analysis and testing of Drug substances/Products.

Personal Information

Date of birth: 11/09/1991

Disclaimer

I hereby declare that the information furnished above is true to the best of my knowledge and belief.

Languages

C++, Diploma in Computer Application (DCA), English, Hindi

Audit Experience

  • USFDA (Investigator Mr. Marcus A RAY).
  • WHO –GENEVA (Auditor-Mr. Ian Thrussel and Mr. Vimal Sachdeva).
  • Julphar UAE (Auditor-Mr. Egopal Reddy, Mr. Mohammad Hatem Shalopy and Mr. Sushil Kumar).
  • Belarus-MOH (Auditor-Mr. Poputriknv Dintry and Mr. Krotara Natallia).
  • MCAZ-Zimbabwe (Auditor-Mr. Admire Nyika and Ms. Eugenia).
  • USFDA (Auditor-Mr. Dipesh Shah and Dr. Rajeev Srivastava).
  • USFDA (Auditor and Investigator Mrs. Teresa Navas).

Activities

Undergone summer training project at the Central Glass and Ceramic Research Institute, CSIR Lab Khurja, Delhi, India worked on chemical testing and characterization of ceramic raw material during training in the CSIR lab Handling Instrument Spectrophotometer, pH Meter, Flame Photometer, Fractional Distillation.

In Ranbaxy Laboratory well Handle Autoclave (steam sterilizer), Dry Heat Sterilizer, Crystalizer, ANFD, Reactors, RO also Validation of all these instrument and Pre post Calibration of Kay validator.

 In Cipla pharmaceutical Ltd worked as analyst in QC-Finished Product where analyze drug substances like tablets, Capsules, effervescent, Multihaller (Related substances, Assay, Contained Uniformity, B.U and sample) and their Physical Analysis, Handling OOS or OOT Investigation Incidence.

In Macleods Pharmaceutical Ltd worked as officer in QC- Analytical method validation where perform all parameters of validation, verification & Tech transfer of drug substances/products (API & Tablets).

In Alembic Pharmaceutical Ltd, I worked on the ophthalmic solution (eye drop) and injectable complete study, i.e., method validation, verification, and tech transfer.

In Mankind Pharmaceutical, I worked as an executive in quality control, finishing the section where we tested and analyzed all test parameters, i.e. Assay, BU, CU, ASTM, RS, CP preservative content, and data report completion to end of analysis

Endo India par formulation worked as senior research associate in analytical development laboratory where prepared validation/verification protocol, report feasibility study protocol and report, method transfer protocol preparation and transfer analysis for the peptide molecules injectable, trace element multirys, and have analysis experience on peptide molecule e.g. glucagon API, glucagon injection, dalbavancine API, dalbavancine injection.

Timeline

Senior Research Associate

Endo-India Par formulation
07.2022 - Current

Executive

Mankind Pharmaceutical Ltd.
10.2021 - 07.2022

Executive

Alembic Pharmaceutical Ltd.
07.2019 - 09.2021

Officer

Macleods Pharmaceutical Ltd.
11.2017 - 07.2019

Management Staff

CIPLA Pharmaceutical
06.2015 - 10.2017

Senior Officer

Ranbaxy Laboratory Ltd.
07.2013 - 06.2015

Master of Science - Industrial Chemistry

Aligarh Muslim University A.M.U

Bachelor of Science - Chemistry & Industrial Chemistry

V.B.S Purvanchal University

XIIth - Science

Maa Durga Ji Sr. Sc. Vidyalaya

Xth - Science

Maa Durga Ji Sr. Sc. Vidyalaya
Prasoon Mishra