Officer, Quality Control Lab
About this role
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:
Company at a glance
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
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