Review chromatograms, raw data, audit trails, and analytical reports for GMP compliance.
Support OOS, OOT, deviation, and laboratory investigations.
Ensure compliance with ALCOA+ data integrity principles.
Manage Deviations, Change Controls, CAPAs, Risk Assessments, and Investigations.
Monitor QMS metrics and prepare quality trend reports.
Support internal, customer, and regulatory audits.
Ensure QMS compliance and continuous quality improvement.
Handle Computer System Validation (CSV) and qualification activities.