Summary
Skills
Work History
Education
Software
Interests
Overview
Generic
Purna Gadwani

Purna Gadwani

Deputy Manager, Quality Assurance
Vadodara,gujarat

Summary

Versatile Deputy Manager specializing in Quality Management System and skilled at planning, implementing and overseeing key improvements to drive high-performing teams. Successfully managed quality control and assurance operations. History of cultivating an open culture with free exchange of information. Skilled at handling regulatory inspections. Pursuing new professional challenges with a growth-oriented company & to be named as an asset worthy.

Skills

Self Motivated

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Work History

Deputy Manager

Quality Assurance, Injectable Division, Alembic Pharmaceutical Ltd.
Vadodara
05.2023 - Current
  • Handling of incidents, OOS, OOT. Manufacturing investigations. Actively involved in all investigations by finding out root cause for OOS, OOT, Incidents , laboratory errors impacting quality analytical results and closure within time as per frequency of SOP.
  • Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
  • Worked collaboratively with cross-functional teams to develop and implement quality systems and processes that met regulatory requirements
  • Worked closely with production, quality control, and regulatory affairs teams to ensure seamless coordination and alignment of quality assurance activities
  • Implemented process improvements and corrective actions based on data analysis and risk assessments, resulting in enhanced product quality and operational efficiency.
  • Handling of regulatory inspections.

Assistant Manager

Quality Control & Quality Assurance, OSD & Injectable Division, Alembic Pharmaceuticals Ltd.
Vadodara
05.2019 - 04.2023
  • Handled team of analysts involved in daily analytical activities.
  • Responsible for planning, supervising, monitoring and handling team knowing their competency for best productivity and least error in quality .
  • To monitor and ensure productivity is as per organization requirements.
  • Planning analytical work and handling troubleshooting at workflow.
  • To ensure timely planning and completion of all analytical activities to avoid any deviations.
  • To ensure timely completion of all analysis and data compilation for timely submission for product filling and its submission to regulatory affair team.
  • Involved in Reduce testing and harmonization activity.
  • Started involving in management of QMS documents.
  • Worked closely with cross-functional teams to develop and implement quality control and assurance processes
  • Quality Assurance: Handling of incidents, OOS, OOT. Manufacturing investigations. Actively involved in all investigations by finding out root cause for OOS, OOT, Incidents , laboratory errors impacting quality analytical results and closure within time as per frequency of SOP.
  • Played a key role in ensuring quality and compliance of pharmaceutical products.
  • Identified areas for process improvement and implemented corrective actions to enhance product quality and operational efficiency.
  • Worked with QxP and helped introduced new systems and processes to achieve challenging objectives

Senior Executive

Quality Control, OSD Division, Alembic Pharmaceuticals Ltd.
Vadodara
05.2015 - 04.2019
  • Responsible for ensuring quality of pharmaceutical products through rigorous testing and analysis
  • Conducted testing and analysis of raw materials, in-process samples, finished products and Stability samples using validated methods and equipment
  • Participated in process improvement initiatives to enhance efficiency and effectiveness of quality control operations.
  • Laboratory Instruments handled- HPLC & UPLC (Agilent and Thermo scientific with Chromeleon 7.2 software, Waters Alliance and Shimadzu with Empower software).
  • Handled regulatory inspection from USFDA to EU-GMP and customer audits.

Executive

Quality Control, OSD Division, Alembic Pharmaceuticals Ltd.
Vadodara
01.2013 - 04.2015
  • Implemented company policies, technical procedures and standards for preserving integrity and security of data, reports, and access.
  • Prepared and reviewed quality control documents, including test protocols, specifications, and reports.
  • Conducted testing and analysis of raw materials, in-process samples, finished products and Stability samples using validated methods and equipment
  • Laboratory instruments handled - UV Spectrophotometer, FTIR, Dissolution apparatus, Disintegration apparatus, Bulk and Tapped Density apparatus, Hardness Tester, Karl Fischer Titrator.

Education

Master of Pharmacy -

Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal
Madhya Pradesh
07.2012 - 2014.05

Bachelor of Pharmacy -

Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal
Madhya Pradesh
08.2008 - 2012.05

Software

LMS

Documentum

Microsoft office

Interests

Reading

Art

Overview

11
11
years of professional experience

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Purna GadwaniDeputy Manager, Quality Assurance