Officer, Quality Control Testing

Amneal Pharmaceuticals LLC; Dahej; On-site; INR 300,000 - 600,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a Quality Analyst to perform in-process and final product quality analyses in a global pharmaceutical manufacturing setting. The role ensures accuracy of results, strict adherence to GMP/GDP, and timely escalation of issues. Responsibilities include testing, documentation, and contributing to continuous improvement.

Candidate should have a B. Pharm (M. Pharm preferred) and at least 1 year of QA experience in pharma, with strong regulatory knowledge and attention

Qualifications

• This role requires a B. Pharm degree with at least 1 year of QA experience in pharma.
• M. Pharm is preferred for advanced QA responsibilities.
• Knowledge of GDP and GMP regulatory requirements is essential.

Responsibilities

• Perform in-process and final product quality analyses and inspections in compliance with regulatory and internal standards.
• Interpret analytical results for accuracy and precision against specifications.
• Operate measuring devices and testing equipment to accept or reject products.
• Test samples of finished goods to verify conformance with quality specs.
• Report process deviations and defects to stakeholders.
• Identify quality issues and recommend preventive measures.
• Maintain complete documentation of all testing activities per GDP and GMP.
• Support corrective and preventive actions from quality investigations.

Skills

Analytical thinking

Attention to detail

Documentation skills

Regulatory knowledge

GDP/GMP awareness

Education

B. Pharm

M. Pharm

Tools

HPLC

Spectrophotometer

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