| || Position Purpose
Support the Regulatory Inspection Quality Lead (RIQL) on priority deliverables for central coordination of inspection management, including preparation activities, operational assistance, and tracking of responses and commitments for assigned inspections.
1. Assist in the coordination of planning and support management for assigned inspections 2. Collaborate with the Regulatory Inspection Quality Lead and the Head of Regulatory Risk and Compliance to ensure a risk based approach for the management of submissions and inspections 3. Liaise with functional quality groups on logistics and operations to ensure a smooth inspection process 4. Provide backroom inspection support as needed in Hyderabad and Mumbai offices or globally as required. 5. Track HA Inspection CAPA commitments in AQWA to ensure timelines are achieved supporting the Inspection Governance Board as needed 6. Support the collation of inspection findings to ensure escalation and mitigation of emerging trends 7. Assists the Regulatory Inspection Quality Lead on enhancements to process management and controlled quality documents (i.e. SOPs, WPs, workflows) related to HA inspections 8. Follow up on receipt of inspection reports from HA 9. Support gathering of information from inspections, audits, regulatory intelligence, KPI/KQI, and other quality activities and initiatives, and ensure successful translation into key needs and improvement opportunities for GDQ 10. Where appropriate, perform effectiveness checks in order to monitor and document that re-occurrence of issues after implementation of improvements is successfully avoided 11. Contribute to the GCP HA Inspection Library Team in the development and maintenance of inspection tools, documents, and training materials 12. Provide assistance for Local and Global Inspections targeting Hyderabad site 13. Support critical quality improvement projects
Key Performance Indicator
• Health Authority Inspections are coordinated efficiently, with responses appropriately reviewed in a timely manner and CAPAs actions effectively. • Inspection risks are proactively identified and effectively mitigated and/or escalated • Provide regular updates to ensure consistency across all inspection responses • Provide global support to global quality deliverables at site
| || Degree in Life Sciences, Pharmacy or Medicines Fluency in English (oral and written), additional languages a plus. Preferably an Asian language e.g. Chinese • • Minimum of 5 years in the pharmaceutical industry, preferably in quality, clinical development, and/or with a Health Authority • Strong organizational awareness (e.g. inter-relationships of departments, business priorities) • Broad understanding of relevant GxP regulations and global expectations of Health Authorities in the area of Pharma Development. • Strong people interaction skills, with ability to successfully lead and engage culturally diverse project teams. • Robust knowledge of Novartis Quality, Drug Development, and respective governance • Ability to work globally to initiate and co-ordinate the work of associates at all levels |