Deputy Manager, Quality Control
About this role
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.
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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