Junior Executive Quality Control

Amneal Pharmaceuticals LLC

Sanand

On-site

INR 400,000 - 700,000

Full time

4 days ago
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Job summary

Amneal Pharmaceuticals LLC in Gujarat, Sanand is seeking a QC Analytical professional to manage samples from receipt to release, ensuring timely analysis and compliant documentation under GMP/GLP.

You'll perform analytical testing, compile results, support equipment qualification and maintenance, participate in stability studies, and help maintain training and regulatory records to uphold quality systems.

Qualifications

  • Master’s degree in science.
  • Good verbal and email communication skills.
  • Attention to detail and strong compliance mindset.
  • Familiarity with GMP and regulatory guidelines for drug manufacturing.
  • Willingness to work shifts per operations.
  • Basic MS Office: Word, Excel, PowerPoint.

Responsibilities

  • Manage sample in/out and tracking across QC analytical projects.
  • Analyze samples using validated methods and compile results.
  • Prepare data packets and submit results for review in a timely manner.
  • Execute approved work schedules and after-hours requests as needed.
  • Perform calibration, maintenance, and qualification of equipment in the QC lab.
  • Support quality systems (deviations, change controls) and SOPs.
  • Maintain training and regulatory records and ensure GDP compliance.
  • Initiate stability studies and coordinate sample prep and testing.

Skills

Verbal communication
Attention to detail
GMP/GLP familiarity
Cross-functional teamwork

Education

Master’s degree in science
Life science Graduate
Life science Post Graduate

Tools

MS Office

Job description

Job Description

As a QC Analytical person, the role involves managing samples from receipt to release, ensuring timely analysis and accurate documentation in compliance with GMP/GLP standards. Responsibilities include performing analytical testing, compiling results, and supporting equipment qualification, calibration, and maintenance. The position also requires participation in stability studies, handling deviations and corrective actions, and maintaining training and regulatory records. Additionally, the role supports audit readiness, SOP development, and continuous improvement initiatives to uphold quality systems and regulatory compliance.

Key Responsibilities
  • Responsible for Sample management activities, including sample in/out, Entry/Exit of samples, Test sample requests, and management of sample request forms, as well as monitoring analysis status and results for all assigned projects in QC analytical.
  • Responsible for analysis of samples, following test methods, generation and compilation of results, data packets preparation, and submission for review of results in a timely manner.
  • Responsible for performing approved work schedules and emergency work requests into action-oriented plans. Must be able to work after hours, any shifts and weekends and shutdown project(s) as required. Provide emergency response to electrical/calibration issues in Instruments.
  • Responsible for completing performance qualification, performance verification, Performance maintenance, and calibration of equipment and instruments promptly in the QC analytical lab.
  • Responsible for supporting the generation and implementation of quality systems (deviations, change controls, etc.) and assisting in the development and maintenance of applicable standard operating procedures and related systems for congruent management and coordination of stability activities.
  • Responsible for writing DRS (Data Recording Sheet), Recording electronic data, archiving raw data, and following GDP procedures as per quality procedures.
  • Responsible for maintaining and Training records for the QC analytical laboratory in accordance with GLP compliance and any other work assigned by the Supervisor or Head of Department.
  • Responsible for initiation of stability studies for drug substance and drug product, maintain stability equipment, perform stability pulls, coordinate sample preparation/submission and testing.
Basic Requirements
  • Qualification: Master’s degree in science
  • 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 working across cross-functional teams
  • Basic MS Office: Word, Excel, PowerPoint

Flexible to work in shifts as per operational requirements.

Qualifications

Life science Graduate & Post Graduate

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