Report Reviewer

Key Responsibilities

• Review routine and non-routine pharmaceutical analytical testing data generated using HPLC and other analytical instruments.
• Review chromatograms, integration parameters, system suitability, calculations, dilution factors, results, and analytical worksheets.
• Verify that testing has been performed according to approved test methods, specifications, SOPs, and applicable pharmacopoeial requirements.
• Review and verify preparation of standards, reagents, mobile phases, sample solutions, and reference standards.
• Check analytical calculations, transcriptions, observations, and final reported results for accuracy and completeness.
• Ensure data integrity, traceability, ALCOA+ principles, and proper documentation of laboratory records.
• Review and authorize analytical test reports before final issuance, as per the laboratory's defined authorization process.
• Identify discrepancies, errors, deviations, abnormal chromatograms, and incomplete analytical records and coordinate appropriate corrective actions.
• Review and support investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and instrument-related issues.
• Review method verification, validation, and analytical troubleshooting records where applicable.
• Ensure proper review of HPLC system suitability parameters and instrument performance records.
• Verify calibration, maintenance, and performance records of HPLC systems and other laboratory equipment.
• Ensure compliance with ISO/IEC 17025, GLP, SOPs, NABL requirements, and internal laboratory quality procedures.
• Coordinate with the Quality Assurance/Quality Control team regarding analytical data review, deviations, CAPA, and compliance requirements.
• Participate in internal audits, external/NABL assessments, proficiency testing, inter-laboratory comparison, and quality improvement activities.
• Ensure proper maintenance and archival of analytical records, raw data, worksheets, chromatograms, and reports.
• Maintain confidentiality and integrity of laboratory data and customer information.
• Support continuous improvement initiatives to improve laboratory efficiency, accuracy, compliance, and productivity.
• Ensure adherence to laboratory safety procedures and proper handling of chemicals, samples, solvents, and reference standards.