QA Auditor

• Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
• Participating in the maintenance of the quality system.
• Forecast, monitor and control the work volume within QAU.
• Plan and organise all activities within the QAU.
• Schedule and perform study, facility and process audits in compliance with SOPs.
• Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate.
• To maintain the CAPA system and follow up CAPA actions.
• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
• Submit audit reports for archiving in accordance with the applicable SOP.
• To approve GMP documentation where applicable.
• To participate in computerized system validation team where applicable.
• Review Standard Operating Procedures for consistency and com...

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