Provide independent Quality Assurance oversight of pharmaceutical and biologics manufacturing operations to ensure compliance with current Good Manufacturing Practices (cGMP).
Perform real-time On-the-Floor (OTF) QA monitoring during manufacturing activities and verify adherence to approved procedures, batch records, and regulatory requirements.
Review manufacturing batch records, solution lot records, and production documentation for accuracy, completeness, and compliance.
Support engineering, process validation, Process Performance Qualification (PPQ), and commercial manufacturing campaigns.
Identify, document, investigate, and track manufacturing deviations through Quality Management Systems.
Participate in root cause investigations and support implementation and effectiveness verification of Corrective and Preventive Actions (CAPAs).
Review and support change control activities, including risk assessments and implementation documentation.
Conduct GMP walkthroughs and provide quality oversight within classified manufacturing and cleanroom environments.
Collaborate with Manufacturing, Quality Control, Microbiology, Engineering, and Validation teams to resolve quality-related issues.
Review environmental monitoring, sterility, endotoxin, and bioburden testing results to ensure compliance with quality standards.
Support microbial investigations, contamination control activities, and sterility assurance programs.
Verify calibration, maintenance, and qualification status of manufacturing and laboratory equipment.
Review laboratory documentation and raw data for compliance with data integrity principles (ALCOA+).
Support batch release and disposition activities through documentation review and reconciliation.
Monitor, analyze, and trend quality metrics using reporting tools such as Power BI and Tableau.
Assist in regulatory inspection readiness activities, internal audits, and continuous improvement initiatives.
Prepare and maintain GMP documentation, investigation reports, and quality records in accordance with company procedures and regulatory requirements.
Utilize electronic systems including SAP, TrackWise, LIMS, Veeva Vault, MODA, MES, and Kneat to support quality and manufacturing operations.
