Officer, Quality Control Lab

Amneal Pharmaceuticals; India; On-site; INR 450,000 - 650,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a QC Analyst for in-process and finished product analyses in a global pharmaceutical QC laboratory. The role emphasizes accurate interpretation of analytical results against specifications and adherence to GDP and GMP standards.

Key responsibilities include operating HPLC, GC, IR, and DSC instruments, testing raw materials, and documenting testing activities. A strong focus on quality, regulatory compliance, and proactive issue prevention is required.

Qualifications

• Analytical chemist with strong attention to precision and accuracy.
• Experience interpreting analytical results against specifications.
• Familiarity with GDP and GMP documentation and compliance.

Responsibilities

• Perform raw material quality analyses in QC lab per regulatory standards.
• Operate instruments such as HPLC, GC, IR, DSC to test samples.
• Interpret results for accuracy and precision against specifications.
• Test random raw material samples to verify conformance with quality specs.
• Document testing activities accurately in line with GDP/GMP requirements.
• Identify quality issues and recommend preventive actions.

Skills

Analytical thinking

Attention to detail

Regulatory knowledge

Education

B. Pharm - Required

M Sc - Required

M. Pharm - Preferred

Tools

HPLC

GC

IR

DSC

Job description

This role is responsible for conducting in-process and final product quality analyses and inspections within a quality control laboratory 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 laboratory 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 laboratory 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 Raw material quality analyses and inspections within the QC laboratory in compliance with regulatory and internal standards.
• To operate the instrument like HPLC, GC, IR and DSC etc..
• 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 raw materials to verify conformance with quality specifications
• Identify ongoing quality issues and recommend preventive measures to avoid potential production problems
• Maintain accurate and complete documentation of all laboratory testing activities in accordance with GDP and GMP requirements
• Support implementation of corrective and preventive actions arising from quality investigations

Additional Responsibilities:

Education:

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

Experience:

• 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses: