Officer, Quality Control Lab

Amneal India

Dahej

On-site

INR 350,000 - 520,000

Full time

9 days ago

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Job summary

Amneal India is seeking a Quality Control Analyst to conduct in-process and final product analyses in the QC lab, ensuring compliance with GMP, GDP, and regulatory standards. You will interpret analytical results, operate testing equipment, and document outcomes accurately.

You will test finished goods, report deviations, and contribute to CAPA processes, with 1+ year of QC experience in pharma preferred. This role is based in India and demands strict adherence to quality protocols.

Qualifications

  • Educational requirements include a B. Pharm with on‑file credentials.
  • M. Pharm is preferred for advanced insights and regulatory exposure.
  • Minimum one year experience in quality control within pharma.

Responsibilities

  • Perform in-process and final product quality analyses and inspections in QC.
  • Interpret results for accuracy and precision against specifications.
  • Operate measuring devices and testing equipment per methods.
  • Test random finished goods for conformance to quality specs.
  • Document deviations and report defects to stakeholders.
  • Identify quality issues and suggest preventive actions.
  • Maintain GMP/GDP compliant documentation for testing activities.
  • Support corrective and preventive actions from investigations.

Skills

Analytical Data Evaluation
Analytical Testing
Chemical Testing
Data Integrity
Documentation Control
Equipment Maintenance
GDP
Laboratory Safety
Technical Documentation

Education

B. Pharm
M. Pharm

Job description

This role is responsible for conducting in-process and final product quality analyses and inspections within a quality control laboratory in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predefined specifications to ensure product integrity. Various measuring devices, testing equipment, and predetermined methods are employed to accept or reject products based on prescribed specifications. The role contributes to identifying ongoing quality issues and preventing potential production problems through proactive laboratory monitoring and timely escalation. Manufacturing process deviations and defects in finished goods are identified, documented, and reported in accordance with Good Manufacturing Practices. Random samples of finished goods are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to laboratory testing methods and quality processes. It operates within a structured quality management framework aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and international pharmaceutical regulations.

Essential Functions
  • Perform in-process and final product quality analyses and inspections within the QC laboratory in compliance with regulatory and internal standards
  • Interpret and evaluate analytical results for accuracy and precision against established specifications
  • Operate measuring devices, testing equipment, and follow predetermined methods to accept or reject products
  • Test random samples of finished goods to verify conformance with quality specifications
  • Report manufacturing process deviations and defects in finished goods to relevant stakeholders
  • Identify ongoing quality issues and recommend preventive measures to avoid potential production problems
  • Maintain accurate and complete documentation of all laboratory testing activities in accordance with GDP and GMP requirements
  • Support implementation of corrective and preventive actions arising from quality investigations
Qualifications

Education:

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 1 year or more in 1 - 4 Years

Specialized Knowledge:

Licenses:

Required Skills
  • Analytical Data Evaluation
  • Analytical Testing & Evaluation
  • Chemical Testing and Analysis
  • Data Integrity & Documentation Security
  • Documentation & Record Control
  • Equipment Cleaning & Maintenance
  • Good Documentation Practices (GDP)
  • Laboratory Safety
  • Technical Documentation
Job Info
  • Job Identification 8777
  • Job Category Quality Control
  • Posting Date 08/29/2026, 03:34 PM
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