Senior Officer QC Testing

Amneal Pharmaceuticals LLC; India; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks a quality control professional to interpret analytical results and ensure product integrity. The role uses measuring devices and predefined methods to accept or reject finished goods, adhering to GDP and GMP standards.

The incumbent will audit processes, document testing activities, report deviations, and support CAPA initiatives to prevent production issues, with 2+ years of experience in QA/QC within pharma.

Qualifications

• Bachelor's degree in Pharmacy required.
• Master's degree in Pharmacy preferred.
• Minimum 2 years of experience; 2–5 years ideal.

Responsibilities

• Perform in-process and final product quality testing.
• Interpret analytical results for accuracy against specifications.
• Operate measuring devices and follow methods to accept/reject products.
• Audit manufacturing processes against internal and regulatory standards.
• Test random finished goods to verify conformance with quality specs.
• Report deviations and defects to relevant stakeholders.
• Identify ongoing quality issues and recommend preventive measures.
• Maintain documentation of all testing activities per GDP and GMP.

Skills

Quality testing

Analytical evaluation

GMP compliance

Documentation

Auditing

Education

B. Pharm

M. Pharm (Preferred)

Tools

Measuring devices

Job description

Job Description:

Description:

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 testing 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 testing and analyses 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

• 2 years or more in 2 - 5 Years