- 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.