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.
Required Experience:
Manager
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 Standa...
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.
Required Experience:
Manager
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