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.
2. 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.
3. Documentation Control
- Review SOPs, Specifications, STPs, Protocols, Reports, and laboratory documents.
- Ensure compliance with Good Documentation Practices (GDP).
- Maintain controlled QC documents and records.
4. 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.
5. 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.
6. 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.
7. 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
