QA Expert, ESO Large Molecules Jobs at Hyderabad AP, India Full Time

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities:Your responsibilities include, but not limited to:• Provide Leadership & manage Quality Assurance Managers in all quality related matters andto ensure that all aspects of the operational business comply with cGMP (Current Goodmanufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual& Policies.• Ensure that all products manufactured by site/External Supplier in addition to theimported products for local site are released to the market according to Novartis QualityStandards.• Oversight of Quality Operations across site. Inbound QA Oversight. Outbound QA Oversight. MBR review and approval. Product release. QA for Quality Control and AS and T. QA Operational Excellence. Initiate and drive local hiring process. Line responsibility and daily walkthrough.• Lead OpEx Projects. Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. Support transfer Projects & validation studies. Track team metrics and ensure KQI /KPI meet requirements. Review and approve text and design. HSE incidents reporting and action follow up.• New equipment commissioning Support (OQ, PQ). Define improvement areas in process and products. Resource and capacity (people and equipment) planning and workload management.• Performance and leadership Support to specialist team. Ensure availability of equipment, chemicals and consumables, AS appropriate. SOP review and revision. Perform local training and monitor training status.• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable).