The Deputy Manager – Quality Control is responsible for managing laboratory operations, stability studies, and quality systems to ensure compliance with regulatory and cGMP standards. The role involves oversight of preventive maintenance, calibration, GLP adherence, documentation review, and data integrity across QC functions. It also includes handling deviations, OOS investigations, change controls, and driving continual improvement through training and SOP implementation.
To ensure the integrity, accuracy, and compliance of Quality Control investigations and documentation through effective review and oversight of Out of Specification (OOS), Out of Trend (OOT), and other quality events. This role ensures adherence to regulatory guidelines, Good Laboratory Practices (GLP), and internal SOPs to support continuous improvement in laboratory quality systems.
• Plan and supervise preventive maintenance, calibration, and verification of QC instruments.
• Ensure timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Maintain strict compliance with GLP, safety protocols, and laboratory housekeeping.
• Prepare and review stability protocols, monitor sample charging/withdrawal, and approve stability reports.
• Investigate deviations, OOS, OOAL, and incidents; implement effective CAPA.
• Review and approve QC-related change controls, SOPs, and specifications.
• Conduct audit trail reviews and ensure electronic data integrity for software-enabled instruments.
• Oversee LIMS operations and ensure accurate documentation and traceability.
• Identify training needs and support skill development for QC personnel.
• Manage analytical column inventory and laboratory standards as per SOPs.
• M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.
Experience:
• 12+ years of experience in QC operations within API manufacturing.
Skills:
• GLP & GDP Compliance – Advanced
• Stability Study Management – Advanced
• Data Integrity & LIMS Operations – Advanced
• Deviation/OOS Investigation – Advanced
• Regulatory Compliance & Documentation – Advanced
• Leadership & People Development – Advanced
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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