<ul><li>Undertake Quality control checks for documentation during clinical phase of biostudy.</li><li>Monitor for compliance with study protocol, during biostudy.</li><li>Check protocol, ICF, CRF and other documents for a biostudy.</li><li>Verify the corrective actions taken against observations during quality audit and to ensure their implementation.</li><li>Check and verify Instrument/System related documentation.</li><li>Ensure compliance with relevant regulatory standards, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and other applicable regulations.</li><li>Conduct internal and external audits to assess compliance with quality standards and regulatory requirements.</li><li>Develop audit plans, execute audits, and generate comprehensive audit reports.</li><li>Contribute to the development and implementation of quality management systems, including the establishment of quality policies, processes, and procedures.</li></ul>

Clinical Quality Control