Summary
Overview
Work History
Education
Skills
Languages
Interests
Timeline
Generic

Nilay J Shah

Blackwood,NJ

Summary

  • Accomplished Senior Quality Control Officer with a proven track record at Apothecon Pharmaceuticals, enhancing product quality through rigorous testing and CAPA management. Leveraged strong work ethic and critical thinking to reduce defect rates significantly. Expert in GMP compliance and team leadership, fostering a culture of continuous improvement and collaboration.
  • Thorough Quality Assurance Manager creates successful quality assurance strategies and processes. Accomplished at identifying deficiencies and initiating solutions to problems. Experienced performing both process and outbound inspections.

Overview

11
11
years of professional experience

Work History

Senior Quality Control Officer

Apothecon Pharmaceuticals
06.2019 - 07.2023
  • Streamlined quality control processes for increased efficiency, resulting in reduced turnaround time for product inspections.
  • Conducted root cause analyses for recurring defects, leading to targeted corrective actions that reduced defect rates significantly.
  • Championed the adoption of advanced analytical tools, enabling more accurate identification of quality issues and faster resolution times.
  • Enhanced product quality by implementing rigorous testing procedures and maintaining strict adherence to industry standards.
  • Supported new product launches by working closely with R&D teams during development stages, ensuring seamless integration into manufacturing processes without compromising quality standards.
  • Maintained detailed documentation for all quality-related activities, providing transparency across departments and facilitating data-driven decision-making processes.
  • Mentored junior Quality Control Officers, sharing expertise and fostering a collaborative team environment focused on continuous improvement.
  • Collaborated with suppliers to ensure timely delivery of high-quality materials, reducing potential delays in production.
  • Actively involved in Standard Management like Working standard, Primary Reference standard,Impurity Standard Qualification as well as its procurement.
  • Working with method validation department with all related activities.

Senior Quality Control Officer

Aalidhara PharmaChem Pvt.Ltd
10.2018 - 06.2019
  • Perform Finished Drug products, Drug substance & Raw material analysis.
  • Troubleshooting of Hight pressure Liquid chromatography(HPLC) & Gas Chromatography(GC).
  • Method Validation Study as per ICH guideline.
  • Developed customized training programs for staff members, enhancing their understanding of quality control best practices and increasing job satisfaction.
  • Mentored junior Quality Control Officers, sharing expertise and fostering a collaborative team environment focused on continuous improvement.

Senior Quality Executive

Zydus Cadila Health Care Ltd,
06.2016 - 05.2018
  • Elevated employee engagement levels by empowering team members with decision-making authority regarding quality control issues.
  • Established a supplier scorecard system to evaluate vendor performance, ensuring consistent delivery of high-quality materials.
  • Enhanced overall production efficiency with continuous improvement initiatives and lean manufacturing practices.
  • Actively Involved in Stability study department, responsible for analysis, Charging and withdrawal of stability samples at various time intervals and also responsible for preparing a stability protocol and its summary sheets.

Quality Control Officer

Amoli Organics Ltd.
07.2015 - 07.2016
  • Analyzing Pharmaceutical Raw materials, Drug substance & finished drug products.
  • Approved incoming materials by confirming specifications and taking measurement tests.
  • Documented inspection results by completing logs.
  • Enhanced product quality by implementing rigorous inspection procedures and protocols.
  • Established strong relationships with suppliers, promoting open communication channels to address potential issues proactively.
  • Created and maintained several databases to track statistical data.
  • Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
  • Inspected items and compared against standards to meet regulatory requirements.
  • Performed routine maintenance and calibration on testing equipment.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Performed tests and inspections to conform to established standards.
  • Developed and implemented procedures to meet product quality standards.
  • Reported problems and concerns to management.

Quality Control Officer

Bajaj Healthcare Ltd.
02.2014 - 01.2015
  • Sampling of Raw materials, Finished drug substance , drug products, Intermediate samples.
  • Analyzing Raw materials, finished drug substance,drug products and in-process & intermediate samples.
  • Handling of various Quality Control instruments i.e. High pressure liquid chromatography (HPLC), Gas Chromatography (GC), Karl Fisher Apparatus, Amine meter, Auto titration, Furrier Transform Infrared spectrometer (FT-IR), UV-Visible spectrophotometer.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.
  • Collected and analyzed data to measure effectiveness of quality control processes.
  • Conducted investigations into questionable test results.
  • Monitored testing procedures and verified performance of tests according to established item specifications and protocol.

Quality Control Trainee

Bharat Parentrals Ltd.
11.2012 - 02.2014
  • Sampling and analyzing Raw materials, finished products and drug substance.
  • Handling of Quality control instrument like UV-Visible spectrometer, FT-IR , Karl fisher apparatus, and auto titration.
  • Created testing protocols to be used across product lines.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.

Education

Master of Science - Pharmaceutical Sciences

Rowan University
Glassboro, NJ
05-2025

Bachelor of Science - Pharmacy

Rajiv Ghandhi University of Health Science
Bangalore, India
08-2012

Skills

  • Quality training
  • Internal audits
  • CAPA management
  • Quality metrics
  • Documentation review
  • Quality management systems
  • Product inspection
  • Process validation
  • Test method development
  • Validation protocols
  • GMP compliance
  • Visual inspection
  • Project management
  • Strong work ethic
  • Teamwork and collaboration
  • Problem-solving
  • Time management
  • Multitasking Abilities
  • Excellent communication
  • Critical thinking
  • Team leadership
  • Decision-making

Languages

English
Full Professional
Hindi
Full Professional

Interests

  • Supporting STEM education initiatives and mentorship programs
  • Youth Development Programs
  • Enjoy hobbies that combine physical activity with outdoor exploration
  • Sustainable Tech Innovations
  • Artificial Intelligence (AI) and Machine Learning

Timeline

Senior Quality Control Officer

Apothecon Pharmaceuticals
06.2019 - 07.2023

Senior Quality Control Officer

Aalidhara PharmaChem Pvt.Ltd
10.2018 - 06.2019

Senior Quality Executive

Zydus Cadila Health Care Ltd,
06.2016 - 05.2018

Quality Control Officer

Amoli Organics Ltd.
07.2015 - 07.2016

Quality Control Officer

Bajaj Healthcare Ltd.
02.2014 - 01.2015

Quality Control Trainee

Bharat Parentrals Ltd.
11.2012 - 02.2014

Master of Science - Pharmaceutical Sciences

Rowan University

Bachelor of Science - Pharmacy

Rajiv Ghandhi University of Health Science

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Nilay J Shah