Job Description
Data and Documentation Review: Perform rigorous, independent review of analytical raw data, calculations, instrument audit trails, and final reports (including OOS and deviation investigations) to ensure compliance with quality standards (ALCOA+).
Compliance Oversight: Review and approve laboratory Standard Operating Procedures (SOPs), equipment calibration/qualification records, and training documentation.
Quality System Management: Participate in the CAPA process by reviewing root cause analyses and verifying the effectiveness of corrective actions; assist in the maintenance and continuous improvement of the Quality Management System (QMS).
Auditing and Readiness: Conduct internal audits of laboratory operations and documentation systems; support regulatory and client inspections.