Assistant Manager QC Lab

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad district is seeking a Quality Control professional responsible for overseeing in-process and final product analyses and inspections in the QC laboratory, ensuring regulatory compliance and adherence to internal specs.

You will interpret results, identify quality issues, operate testing equipment, audit processes, and sample finished goods to verify conformance, while documenting activities per GMP and GDP.

Qualifications

• Bachelor's degree in BA/BS or B.Sc. is required.
• Master's degree in Science is preferred.
• 8+ years of experience in quality control/QA in pharma.

Responsibilities

• Conduct in-process and final product quality analyses and inspections in compliance with regulatory and internal standards.
• Interpret and evaluate laboratory testing results for accuracy and precision against established specifications.
• Identify ongoing quality issues and implement preventive measures to avoid production disruptions.
• Operate measuring devices, testing equipment, and prescribed methodologies to accept or reject products.
• Audit and monitor manufacturing processes and laboratory outputs against defined internal and regulatory quality standards.
• Test random samples of finished goods to verify product conformance and laboratory integrity.
• Report manufacturing process deviations and defects in finished goods to relevant stakeholders.
• Support continuous improvement initiatives to reduce costs, defects, and rework in laboratory operations.
• Maintain documentation and records in accordance with GMP and GDP requirements.

Skills

In-process QA

Final product QA

Laboratory testing

Measuring devices

Process auditing

Sampling finished goods

Deviation reporting

Continuous improvement

Documentation

Education

B.Sc in Science

M.Sc

Job description

Job Description:

Description:

This role is responsible for overseeing in-process and final product quality analyses and inspections within the quality control laboratory in compliance with regulatory standards and internal specifications. The position ensures that all laboratory testing activities are conducted with accuracy and precision, interpreting results against established acceptance criteria. It plays a critical role in identifying ongoing quality issues and preventing potential production failures before they escape. The role applies various measuring devices, testing equipment, and predetermined methodologies to accept or reject products based on defined specifications. It audits and monitors manufacturing processes and laboratory outputs against both internal and regulatory quality standards. Random sampling of finished goods is conducted to verify product conformance and laboratory integrity. Manufacturing process deviations and defects in finished goods are systematically reported and escalated for corrective action. The position contributes to continuous improvement initiatives aimed at reducing defects, rework, and quality-related costs within the Quality Control Laboratory function.

Essential Functions:

• Conduct in-process and final product quality analyses and laboratory inspections in compliance with regulatory and internal standards
• Interpret and evaluate laboratory testing results for accuracy and precision against established specifications
• Identify ongoing quality issues and implement preventive measures to avoid production disruptions
• Operate measuring devices, testing equipment, and prescribed methodologies to accept or reject products
• Audit and monitor manufacturing processes and laboratory outputs against defined internal and regulatory quality standards
• Test random samples of finished goods to verify product conformance and laboratory integrity
• Report manufacturing process deviations and defects in finished goods to relevant stakeholders
• Support continuous improvement initiatives to reduce costs, defects, and rework in laboratory operations
• Maintain documentation and records in accordance with GMP and GDP requirements

Additional Responsibilities:

Qualifications

Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M.Sc. - Preferred

Experience:

• 8 years or more in 8 - 10 Years

Specialized Knowledge:Licenses:

Requirements: