Essential Functions – Officer, Quality Control
• Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
• Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
• Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
• Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
• Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
• Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
• Enter, verify, and maintain accurate analytical data and sample status in LIMS.
• Participate in training programs and support knowledge sharing within the QC team.
• Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.
Qualifications
Education
• M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.
Experience
• 5–8 years of hands-on experience in QC operations within an API manufacturing facility.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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