Officer, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad; On-site; INR 300,000 - 500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, Gujarat, is seeking a quality analyst to ensure compliance with regulatory standards. The role involves conducting in-process and final product quality analyses, interpreting analytical results, and supporting continuous improvement initiatives in a pharmaceutical manufacturing environment.

The ideal candidate holds a B. Pharm with 1-4 years of relevant experience. Skills in analytical testing, documentation practices, and laboratory safety are essential. This position offers an opportunity to contribute to product integrity and quality assurance.

Qualifications

• Bachelor's degree in Pharmacy is required; Masters in Pharmacy is preferred.
• 1 to 4 years of experience in the relevant field is required.

Responsibilities

• Perform quality analyses and inspections in compliance with standards.
• Evaluate analytical results for accuracy against specifications.
• Report manufacturing process deviations and defects.
• Document testing activities in accordance with GDP and GMP.

Skills

Analytical Data Evaluation

Analytical Testing & Evaluation

Chemical Testing and Analysis

Data Integrity & Documentation Security

Documentation & Record Control

Equipment Cleaning & Maintenance

Good Documentation Practices (GDP)

Laboratory Safety

Technical Documentation

Education

B. Pharm

M. Pharm

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 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

Qualifications

• Education: B. Pharm – Required; M. Pharm – Preferred
• Experience: 1 to 4 years in relevant field

Required Skills

• Analytical Data Evaluation
• Analytical Testing & Evaluation
• Chemical Testing and Analysis
• Data Integrity & Documentation Security
• Documentation & Record Control
• Equipment Cleaning & Maintenance
• Good Documentation Practices (GDP)
• Laboratory Safety
• Technical Documentation