Summary
Overview
Work History
Education
Skills
Certification
Languages
Projects
Accomplishments
Extracurricular Activities
Training
Disclaimer
Softwares Handled
Timeline
Generic

P. VASANTHI M.Pharm.,(MBA)(PMP)(CQA)

Hyderabad

Summary

Motivated individual with a strong background in laboratory research and quality assurance. Proficient in time management and organization excels in diverse settings. Diligent project management specialist successfully plans, develops and implements projects. Expertise and trained in Analytical document review and QMS.

Overview

20
20
years of professional experience
1
1
Certification

Work History

Scientist-II/Assistant Manager

Hetero Labs
Hyderabad
04.2025 - Current
  • Leading a GLP team and handling ownership for the R&D unit.
  • Qualified and expert in reviewing Analytical documents
  • Lead investigator in OOS, Change control ,Lab investigation and Deviation
  • Experienced in conducting sessions related to projects.
  • Contributed in preparation of regulatory (32p83a) to health authorities.
  • Mentored new employees in training software's and documentation practice.
  • Supported in GCA,FDA audits as Scribe, Runner and reviewer.
  • Expert in preparing Sops, working instruction and stability protocol.
  • Performed Analysis,Qualification,development,Method transfer,Calibration and Validation activities
  • Supported in Analytical lab setup during Novartis Mumbai OTC to Hyderabad.

Scientist-Project lead

GlaxoSmithKline
Hyderabad
10.2015 - 06.2018

Analytical scientist-I

NovartisHealthCarePrivateLimited
Mumbai/Hyderabad
01.2012 - 09.2015

Junior Scientist

Actavis Pharma
Chennai
12.2009 - 01.2012

Officer

Shasun Drugs And Chemicals
Pondicherry
05.2007 - 12.2009

QC Chemist

AToZ Pharmaceuticals
Chennai
02.2005 - 05.2005

Education

Masters In Pharmacy - Pharmaceutical Analysis

Sri Ramakrishna Institute Of ParaMedical Sciences
Coimbatore

Bachelor Of Pharmacy -

S.B.College Of Pharmacy
Sivakasi

Skills

  • Project lead-Analytical R&D
  • Quality Assurance
  • Regulatory
  • Lab Data integrity
  • Compliance
  • Qualified reviewer
  • Skilled in Business Intelligence using Power BI
  • Lead Investigator-Lab investigations
  • CAPA
  • Deviations
  • Decision making
  • Problem solving
  • Six Sigma Yellow and Green Belt holder

Certification

  • Global Corporate Certification training as a 'Lead investigator for Lab Investigations'(88%) from Novartis.
  • Lean Six Sigma Green Belt and Yellow belt certification course from Benchmark Six Sigma.
  • Certified in Presentation fundamentals
  • Certified in MS-Office-XP
  • Certified Lifesaver Firesaver and emergency preparedness
  • Certified in Power Business intelligence (BI)
  • Certified in Structured query language (SQL)
  • Certified in Data Visualization using Tableau

Languages

English, Tamil, Hindi(Certified)

Projects

Author for the article Simultaneous densitometric determination of ivermectin and albendazole by HPTLC (Published on 2011/8) in Journal of Planar chromatography-Modern TLC.

Accomplishments

  • Received Above and Beyond Award for the Project ownership of Syrups and Gels in Novartis Healthcare Pvt ltd.
  • Received Appreciation award for the Preparation of Global SOP of Manual Integration Guidance.
  • Received Global Employee Recognition Appreciation Award for 'Excellent execution of Pain category project, generation of 3months stability report and CMC documents by demonstrating work across boundary and drive performance' in GSK.

Extracurricular Activities

Waters AcQuity UPLC (Ultra performance liquid chromatography) Waters Alliance HPLC(high performance liquid chromatography) Agilent 1200DAD HPLC Shimadzu LC-20 HPLC Shimadzu LC-10AT HPLC CAMAG HPTLC Spectro fluoriometry (Jasco) JASCO & Shimadzu UV-Visible Spectrophotometer Jasco & ShimadzuFT-IRSpectrometry Dissolution Apparatus-Electrolab,Lab India and Erweka Disintegration Apparatus KF Titrator-Metrohm Potentiometer-Metrohm Viscometer and hardness tester LOD Moisture Balance,Wateractivity meter and Halogen Moisture analysis Titrimetric analysis

Training

  • Pursuing ISO-9001-2015 QMS Lead Auditor
  • Pursuing PMP from PMI Certified Lead Investigator
  • Lean Six Sigma –Green belt
  • [MBA –Project Management (In progress)]

Disclaimer

I hereby declare that the above-furnished details are true to the best of my knowledge and belief.

Softwares Handled

  • GLIMS
  • CLS
  • Diga
  • Empower3
  • Phoenix(regulatory)

Timeline

Scientist-II/Assistant Manager

Hetero Labs
04.2025 - Current

Scientist-Project lead

GlaxoSmithKline
10.2015 - 06.2018

Analytical scientist-I

NovartisHealthCarePrivateLimited
01.2012 - 09.2015

Junior Scientist

Actavis Pharma
12.2009 - 01.2012

Officer

Shasun Drugs And Chemicals
05.2007 - 12.2009

QC Chemist

AToZ Pharmaceuticals
02.2005 - 05.2005

Masters In Pharmacy - Pharmaceutical Analysis

Sri Ramakrishna Institute Of ParaMedical Sciences

Bachelor Of Pharmacy -

S.B.College Of Pharmacy

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P. VASANTHI M.Pharm.,(MBA)(PMP)(CQA)