Summary
Overview
Work History
Education
Skills
Auditexperience
Languages
Timeline
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Hiral Pande

New Hyde Park,NY

Summary

Accomplished Senior Quality Control Microbiologist with over 10 years of experience in the pharmaceutical industry. Expertise in managing quality systems, performing microbiological and analytical testing, and ensuring regulatory compliance. Demonstrated success in leading teams, executing audits, and implementing quality control processes to ensure product safety and efficacy. Adept at solving complex problems, optimizing laboratory operations, and driving continuous improvement.

Overview

13
13
years of professional experience

Work History

Senior Quality Control Microbiologist

Truecare Biomedix
09.2019 - 02.2024
  • Led Quality Management System (QMS) activities for the microbiology and quality control departments, ensuring adherence to current guidelines and industry standards and coordination with external laboratories for additional testing.

Quality Control Microbiologist

Aculife Healthcare Pvt Ltd
06.2017 - 08.2019
  • Administered QMS activities for microbiology departments, including SOP preparation and review.

Quality Control Microbiologist

Truecare Biomedix
03.2016 - 06.2017
  • Maintained and calibrated analytical equipment, including HPLC, dissolution apparatus, and TOC analyzers.

Quality Control Microbiologist

Oasis Laboratory
08.2015 - 03.2016
  • Conducted microbial enumeration, sterility testing, and endotoxin testing and microbial assay in accordance with SOPs.

Quality Control Microbiologist & Senior QA Executive/Management Representative

Stabicoat Vitamins
04.2011 - 08.2015
  • Performed microbial limit tests, microbiological assays, and water testing to ensure product quality.

Education

Bachelor of Science in Microbiology -

S.P. University
01.2010

Skills

  • Quality Management Systems (QMS) and Regulatory Compliance (cGMP, GLP, SOP)
  • Microbiological Testing and Analytical Techniques (HPLC, TOC)
  • Training and Development
  • Audits and Inspections
  • Documentation and Report Management (SAP)
  • Problem-Solving and CAPA Implementation
  • Continuous Improvement and Process Optimization
  • Microbial Isolation and Identification
  • Gram staining
  • Water Testing (Potable, Purified, Water for Injection)
  • Microbial Limit Testing and Pathogen Testing
  • Microbial Assays and Sterility Testing
  • Bacterial Endotoxin Testing
  • Environment Monitoring

Auditexperience

Conducted and participated in audits by Central WHO, and various customer audits.

Languages

English
Elementary
Hindi
Native or Bilingual
Gujarati
Native or Bilingual

Timeline

Senior Quality Control Microbiologist

Truecare Biomedix
09.2019 - 02.2024

Quality Control Microbiologist

Aculife Healthcare Pvt Ltd
06.2017 - 08.2019

Quality Control Microbiologist

Truecare Biomedix
03.2016 - 06.2017

Quality Control Microbiologist

Oasis Laboratory
08.2015 - 03.2016

Quality Control Microbiologist & Senior QA Executive/Management Representative

Stabicoat Vitamins
04.2011 - 08.2015

Bachelor of Science in Microbiology -

S.P. University

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Hiral Pande