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Amneal India is seeking a Quality Control Analyst to conduct in-process and final product analyses in the QC lab, ensuring compliance with GMP, GDP, and regulatory standards. You will interpret analytical results, operate testing equipment, and document outcomes accurately.
You will test finished goods, report deviations, and contribute to CAPA processes, with 1+ year of QC experience in pharma preferred. This role is based in India and demands strict adherence to quality protocols.
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.
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