Job Summary

Responsible for reviewing Quality Control documentation, analytical data, and QMS records to ensure compliance with cGMP, GLP, GDP, Data Integrity (ALCOA+), and regulatory requirements. Supports investigations, CAPA, audits, and continuous improvement of the Quality Management System.

Roles & Responsibilities1. Analytical Data Review
Review analytical raw data, test results, and laboratory records.
Verify calculations, chromatograms, and analytical reports.
Review and approve Certificates of Analysis (COA).
Ensure compliance with ALCOA+ and Data Integrity principles.
Quality Management System (QMS)
Review and manage Deviations, OOS, OOT, CAPA, Change Controls, and Incidents.
Ensure timely investigation, documentation, and closure of QMS records.
Participate in risk assessments and quality improvement activities.
Documentation Control
Review SOPs, Specifications, STPs, Protocols, Reports, and laboratory documents.
Ensure compliance with Positive Documentation Practices (GDP).
Maintain controlled QC documents and records.
Regulatory Compliance




Ensure laboratory activities comply with cGMP, GLP, ICH, USFDA, EU GMP, WHO GMP, and applicable regulatory guidelines.
Support regulatory, customer, and internal audits.
Prepare and review audit responses and corrective actions.
Laboratory Compliance
Review instrument usage logs, calibration, qualification, and maintenance records.
Verify sample receipt, testing, and documentation processes.
Ensure timely review and release of laboratory documentation.
Investigation & CAPA
Review investigations related to OOS, OOT, Deviations, and laboratory incidents.
Verify Root Cause Analysis (RCA) and CAPA effectiveness.
Monitor implementation and closure of corrective actions.
Training & Continuous Improvement
Train QC personnel on GMP, GDP, Data Integrity, and QMS procedures.
Participate in process improvements and compliance initiatives.
Promote a quality culture within the laboratory.

Pay: ₹600,000.00 - ₹800,000.00 per year

Work Location: In person

📌 Qc Reviwer Thane
🏢 Great Pacific Export
📍 Thane