Job Title: Senior QC Reviewer
Department: Quality Control (QC)
Location: Turbhe Navi Mumbai Manufacturing Plant

Job Summary

The Senior QC Reviewer is responsible for reviewing and approving analytical data, laboratory records, and quality control documentation to ensure compliance with Good Manufacturing Practices (GMP), Valuable Laboratory Practices (GLP), data integrity principles (ALCOA+), and applicable regulatory requirements. The role provides technical guidance to QC analysts, supports investigations, and ensures timely review of laboratory documentation for batch release.

Key Responsibilities
- Review analytical data, raw data, worksheets, chromatograms, spectra, and laboratory notebooks for accuracy, completeness, and compliance.
- Review and approve Certificates of Analysis (COA), analytical reports, and laboratory documentation.
- Verify analytical calculations, data transcription, specifications, and test methods.
- Ensure compliance with GMP, GLP, GDP, ALCOA+, and data integrity requirements.
- Review instrument logbooks, calibration, qualification,



and maintenance records.
- Identify and resolve documentation errors, discrepancies, and review comments before batch disposition.
- Review and support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, laboratory incidents, CAPA, and change controls.
- Provide technical guidance and mentoring to QC Analysts and QC Reviewers.
- Coordinate with QA, Production, Warehouse, and Regulatory Affairs to ensure timely completion of documentation.
- Ensure review activities are completed within established timelines to support batch release.
- Participate in method validation, method transfer, stability studies, and analytical troubleshooting, where applicable.
- Support internal audits, customer audits, and regulatory inspections by providing required laboratory documentation.
- Ensure compliance with SOPs, pharmacopoeial requirements (IP/USP/BP/EP), and ICH guidelines.
- Recommend a

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