Assistant Manager, Quality Control

Amneal Pharmaceuticals; Dahej; On-site; INR 2,000,000 - 3,800,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Deputy Manager – Quality Control to lead laboratory operations, stability studies and quality systems. You will ensure GLP adherence, maintain data integrity, and oversee documentation across QC functions in a fast‑paced API manufacturing environment.

The role includes handling deviations, OOS investigations, change controls, CAPA, and driving continuous improvement through training and SOP implementation.

Qualifications

• M.Sc / M.Pharm / B.Pharm in Pharmacy/Chemistry or related field.
• 12+ years of QC operations experience in API manufacturing.
• Proven expertise in GLP/GDP, data integrity and QA documentation.

Responsibilities

• Plan and supervise QC laboratory operations and stability studies.
• Review deviations, OOS investigations, and CAPA implementations.
• Oversee QC documentation, change controls, and SOP adherence.
• Audit trails review and ensure electronic data integrity for software-enabled instruments.
• Lead training and skill development for QC personnel.

Skills

GLP & GDP Compliance

Stability Study Management

Data Integrity & LIMS Operations

Deviation/OOS Investigation

Regulatory Compliance & Documentation

Leadership & People Development

Education

M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred

Job description

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