Officer, Quality Control Testing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 300,000 - 420,000; Full time

Job summary

Amneal Pharmaceuticals in Gujarat seeks a Quality Analyst to conduct in-process and final product analyses in line with GMP and regulatory standards. The role focuses on accuracy, precision, and documentation of testing activities.

You will operate measuring devices, test finished goods, report deviations, and support CAPA from quality investigations in a global manufacturing setup.

Qualifications

• Quality analysis and testing techniques within pharma manufacturing.
• Familiarity with GDP and GMP documentation and regulatory expectations.
• Attention to accuracy, precision, and compliant record-keeping.

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 specifications.
• Operate measuring devices and testing equipment to accept or reject products.
• 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 propose preventive measures.
• Maintain accurate documentation of all testing activities per GDP and GMP.
• Support corrective and preventive actions arising from quality investigations.

Skills

Quality analysis

GDP/GMP knowledge

Documentation

Education

B. Pharm

M. Pharm

Job 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.

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
• 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

Education

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

Experience:

• 1 year or more in 1 - 4 Years