Summary Ensure that for all Novartis products - manufactured by external supplier in scope of personal portfolio - all aspects of manufacturing testing release and distribution import comply with international standards of GMP regulatory requirements the Novartis Group Quality Manual and the applicable Quality Agreements Key Responsibilities Acts according to Novartis values and behaviors Provides direction and formulates strategies to maintain and improve the external supplier quality oversight Establishes and maintains quality relationship with suppliers in scope Acts as Single Point of Contact SPOC for all quality related activities at assigned external suppliers Provides the quality presence and input to technical meetings with the external suppliers and establishes valuable working relationships External supplier quality related activities are further described in the subsequent paragraphs Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties Supplier qualification Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks Ensures site readiness for regulatory inspections and quality audits and supports during such events Routine monitoring Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews Critically assesses the performance of the product and process performed at the external supplier Escalate any issues or instances of instability as necessary Implements and monitors Key Performance Indicators KPI and ensures that all parts of ESO are working in a consistent manner against harmonized expectations Initiates corrective actions when necessary and performs follow-up on resulting measures Maintains relevant data bases in a t

📌 Senior Qa Expert, Eso Large Molecules (Hyderabad)
🏢 Novartis
📍 Hyderabad