Trainee Officer, QC Testing

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 350,000 - 550,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a Quality Analyst to perform in-process and finished product quality analyses to ensure compliance with GDP and GMP. You will interpret analytical results, operate testing equipment, and document all testing activities in a strict quality framework.

Prior experience in a pharmaceutical manufacturing setting is desirable. Responsibilities include auditing processes, reporting deviations, and supporting CAPA initiatives to prevent production problems while

Qualifications

• B. Pharm is required.
• M. Pharm is preferred.

Responsibilities

• Perform in-process and final product quality analyses and inspections in compliance with regulatory and internal standards.
• Interpret and evaluate analytical results for accuracy and precision against established specifications.
• Operate measuring devices and testing equipment per predetermined methods to accept or reject products.
• Audit and monitor manufacturing processes 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 to relevant stakeholders.
• Identify ongoing quality issues and recommend preventive measures to avoid production problems.
• Maintain complete documentation of testing activities in accordance with GDP and GMP requirements.
• Support implementation of corrective and preventive actions arising from quality investigations.

Education

B. Pharm

M. Pharm

Job description

Description

JOB DESCRIPTION

This role is responsible for conducting in-process and final product quality analyses and inspections 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 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 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 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:

• 1 year or more in 1 - 4 Years