Assistant Manager / Deputy Manager- Analytical QA

Role & responsibilities

• Ensure compliance with GLP, GMP, Data Integrity, and regulatory requirements.
• Conduct laboratory GLP rounds and verify documentation, environmental monitoring, instrument usage logs, and status labeling.
• Review analytical reports, chromatograms, calibration records, working standards, and stability documentation.
• Review and prepare QA SOPs and ensure effective implementation.
• Handle stability activities including protocol review, sample pull-out verification, testing schedules, and stability reports.
• Review raw material and packaging material analytical documentation.
• Handle OOS, OOT, Incidents, Deviations, CAPA, and Market Complaint investigations.
• Perform trend analysis and ensure timely closure of investigations.
• Conduct spot audits and ensure compliance with quality systems.
• Review audit trails and ensure data integrity compliance.
• Coordinate internal training programs and maintain training records.
• Ensure compliance with cGMP, GLP, and applicable regulatory guidelines.