Assistant Manager, Quality Control

Amneal Pharmaceuticals • Full-time • Dahej, IN • 1w ago

Job Description

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.

Qualifications

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

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