Junior Executive, Quality Control

Amneal Pharmaceuticals

Ahmedabad, Gujarat, India0–2 yrs57m agovia LinkedIn

About the Role

The QC (Molecular Biology) role in Quality Control involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards.

Key Responsibilities

  • Sample management activities, including sample in/out, entry/exit, test sample requests, and management of sample request forms.
  • Monitoring analysis status and results for all assigned projects in QC analytical.
  • Analysis of samples following test methods, generation and compilation of results, and preparation of data packets for review.
  • Performing approved work schedules and emergency work requests.
  • Completing performance qualification, performance verification, performance maintenance, and calibration of equipment and instruments.
  • Supporting the generation and implementation of quality systems (deviations, change controls, etc.).
  • Assisting in the development and maintenance of applicable standard operating procedures (SOPs) and related systems for stability activities.
  • Writing DRS (Data Recording Sheet), recording electronic data, archiving raw data, and following GDP procedures.
  • Maintaining training records for the QC analytical laboratory in accordance with GLP compliance.
  • Initiation of stability studies for drug substance and drug product, maintaining stability equipment, performing stability pulls, and coordinating sample preparation/submission and testing.
  • Providing emergency response to electrical/calibration issues in instruments.
  • Upholding quality systems and regulatory compliance.

Requirements & Tech Stack

  • GMP
  • GLP
  • MS Office: Word, Excel, PowerPoint

Qualifications

  • Master’s degree in science.
  • Life science Graduate & Post Graduate.
  • Good verbal and email communication skills.
  • Attention to detail and strong compliance mindset.
  • Familiarity with GMP and various regulatory guidelines for drug manufacturing.
  • Curiosity to read, learn, and work across cross-functional teams.
  • Flexible to work in shifts as per operational requirements, including after hours, any shifts, weekends, and shutdown projects.

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