1. Drive the self-inspection program at Intas-Biopharma site. Ensure the self-inspection program run as per defined schedule.
2. Perform risk assessment to determine the frequency of the self- inspection. Ensuring the appropriate CAPAs are identified and implemented in appropriately.
3. Management of external quality audits. Responsible to facilitate for the management of backroom, coordinate the auditors request, works as scribe during audit, preparation of response etc 4. Tracking and follow up of internal and external audit CAPA.
5. Verification of CAPA effectiveness of internal and external audit CAPAs.
6. Provide the necessary information/support to health authority, business partner and customer as per regulations and agreement respectively.
7. Preparation and review of the Quality Technical agreement with Business partner/Customer. Follow up and track the renewal of the Agreement with stakeholders.
8. Gap assessment of corporate guidelines, other site audit observations, regulatory guidelines.
9. Gap assessment of extended CAPA from the other site and tracking of CAPA.
10. Responsible for preparation, review and revision of SOPs related to audit and compliance.