Job Description
Role Overview
Key Responsibilities
Key Responsibilities
- 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...