Quality Control Reviewer

Job Summary

The QC Reviewer is responsible for reviewing analytical data, laboratory records, and batch-related documents to ensure compliance with GMP, regulatory requirements, and internal quality standards. The role involves verification of test results for raw materials, in-process samples, finished products, and stability studies related to small volume injectables.

The QC Reviewer ensures accuracy, completeness, and integrity of documentation, identifies discrepancies, and coordinates with laboratory personnel for timely resolution. The position plays a critical role in maintaining data integrity and ensuring product quality before batch release.

Responsibilities

• Review of analytical reports, raw data, and laboratory notebooks.
• Verification of test results against specifications and standard test methods.
• Ensuring compliance with GMP, GLP, and regulatory guidelines.
• Review of stability data and environmental monitoring records.
• Identification and reporting of OOS (Out of Specification), OOT (Out of Trend), and deviations.
• Coordination with QC analysts and QA team for investigation and closure of discrepancies.
• Ensuring data integrity and adherence to ALCOA+ principles.
• Maintaining proper documentation and audit readiness.

Required Skills

• GMP compliance
• GLP knowledge
• Data integrity (ALCOA+)
• Analytical data review
• OOS/OOT handling
• Documentation review
• Regulatory compliance
• Environmental monitoring
• Stability studies knowledge

Job Details

• Department: Quality Control
• Job Type: Full-time
• Experience: 3-5 years
• Location: Neemrana, Rajasthan