Senior Scientist, Manufacturing Science & Technology
Amneal Career Sites
Assistant 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.
• 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
Frequently Asked Questions
Is the salary disclosed for the Assistant Manager, Quality Control position at Amneal Career Sites?
The salary for this Assistant Manager, Quality Control role at Amneal Career Sites is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Assistant Manager, Quality Control position at Amneal Career Sites located?
This Assistant Manager, Quality Control role at Amneal Career Sites is based in Dahej SIR, Gujarat, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Assistant Manager, Quality Control role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Assistant Manager, Quality Control role at Amneal Career Sites.
How do I apply for the Assistant Manager, Quality Control position at Amneal Career Sites?
Click the "Apply Now" button on this page. You will be redirected to Amneal Career Sites's official application portal hosted on oraclecloud where you can submit your application directly.
When was the Assistant Manager, Quality Control job at Amneal Career Sites posted?
This Assistant Manager, Quality Control position at Amneal Career Sites was posted on Aug 5, 2026. Apply as soon as possible — early applications are often reviewed first.
Assistant Manager, Quality Control
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.