<ul><li>Develop, implement, and maintain quality assurance procedures, systems, and standards to ensure compliance with regulatory and customer requirements.</li><li>Conduct regular inspections and audits of raw materials, in-process products, and finished goods to ensure adherence to quality standards.</li><li>Review and analyze batch records, SOPs, and other production documentation to ensure completeness and compliance.</li><li>Coordinate with the production and quality control teams to resolve quality issues and implement corrective actions.</li><li>Assist in the preparation for internal and external quality audits and regulatory inspections.</li><li>Support root cause analysis and problem-solving for non-conformances and deviations, ensuring corrective/preventive actions (CAPA) are implemented.</li><li>Review and approve quality documents such as specifications, validation protocols, and batch records.</li><li>Maintain records of quality control data, audit reports, and CAPA effectiveness.</li></ul>

Executive/Sr. Executive-Quality Assurance