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.