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.

📌 Report Reviewer (Manesar)
🏢 Vardan EnviroNet
📍 Manesar