Senior Officer, QC Testing

Amneal Pharmaceuticals LLC; Dahej; On-site; INR 450,000 - 600,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a QA/QC Analyst to interpret and evaluate analytical results, ensuring product integrity. The role uses industry-standard testing equipment and predefined methods to accept or reject products and to document all activities within GDP and GMP frameworks.

The incumbent will support continuous improvement by identifying quality issues, escalating promptly, and contributing to preventive actions in line with ICH guidelines and Indian regulations.

Qualifications

• 2–5 years of experience in quality testing for pharmaceuticals.
• Experience interpreting analytical results against specifications.

Responsibilities

• Perform in-process and final product quality testing in line with GMP/GDP.
• Interpret analytical results for accuracy and precision against specifications.
• Operate measuring devices and testing equipment per defined methods to accept/reject products.
• Audit and monitor manufacturing processes against internal and regulatory standards.
• Test samples of finished goods to verify conformance with quality specs.
• Report deviations and defects to stakeholders.
• Identify ongoing quality issues and recommend preventive measures.
• Maintain complete documentation of testing activities as per GDP/GMP.

Skills

Quality testing

Regulatory compliance

Documentation

Problem solving

Education

B. Pharm

M. Pharm

Tools

Measuring devices

Testing equipment

Job description

Description

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 testing 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 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 testing and analyses 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
• Audit and monitor manufacturing processes and outputs against defined internal and regulatory quality standards
• 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 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

• 2 years or more in 2 - 5 Years