Trainee Officer, QC Testing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 400,000 - 680,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Quality Analyst to conduct in-process and final product quality analyses and inspections within a global pharmaceutical manufacturing environment. The role requires interpreting analytical results for accuracy against specifications, operating measuring devices, and ensuring compliance with GDP and GMP standards.

Responsibilities include auditing processes, testing samples, reporting deviations, and contributing to continuous quality improvements in accordance

Qualifications

• B. Pharm degree is required.
• M. Pharm degree is preferred.
• 1 year or more of experience in quality analysis and inspection (1–4 years).

Responsibilities

• Perform in-process and final product quality analyses and inspections per regulatory and internal standards.
• Interpret and evaluate analytical results for accuracy and precision against specifications.
• Operate measuring devices and testing equipment to accept or reject products.
• Audit manufacturing processes against internal and regulatory standards.
• Test finished goods samples to verify conformance with quality requirements.
• Document and report manufacturing deviations and defects in finished goods.

Skills

Quality analysis

GMP/GDP

Regulatory compliance

Documentation

Education

B. Pharm

M. Pharm

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.

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

Additional Responsibilities

QUALIFICATIONS

Education

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

Experience:

• 1 year or more in 1 - 4 Years

Specialized Knowledge:

Licenses: