Officer Quality Control

Amneal Pharmaceuticals LLC; Sanand; On-site; INR 400,000 - 600,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a QC Analyst for in-process and final product quality analysis at our Gujarat facility. The role involves interpreting analytical results, operating testing equipment, and ensuring conformity with established specifications under GMP/GDP guidelines.

Candidates should have 1–4 years of experience in a QC environment and hold a B. Pharm or M.Sc degree. The position requires strict adherence to regulatory standards and proactive quality improvement.

Qualifications

• 1–4 years of experience in a QC department.

Responsibilities

• Perform in-process and final product quality analysis 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

M.Sc

Job description

Job Description:

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 analysis 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

Qualifications

Education: B. Pharm B. Pharm/ M.Sc - Required

Experience: 1 to 4 Years in QC department

Specialized Knowledge: Licenses:

Requirements: