Manager - Quality Assurance ( QMS)-API @ Kazipalli

Job description

**Role & responsibilities** - Manage and oversee **Quality Management System (QMS)** activities in API manufacturing. - Handle **deviations, CAPA, change controls, incidents, and investigations**. - Review and approve **SOPs, protocols, reports, and quality documentation**. - Ensure compliance with **cGMP, data integrity, and regulatory requirements**. - Conduct and coordinate **internal audits** and support external regulatory audits. - Monitor **market complaints, product quality reviews (PQR), and risk assessments**. - Ensure effective implementation of **quality systems and continuous improvement initiatives**. - Coordinate with cross-functional teams for compliance and closure of quality observations.