Manager Compliance - Sterile

Role & responsibilities

1. Handling of Internal and External Quality Audit.
2. Co-ordinate the pre-inspection process with CFT co-ordinations.
3. Management of inspection team and SMEs during inspection.
4. Draft, facilitate and ensure timely inspection response and monitor CAPA timelines.
5. Monitoring and tracking of various compliance actions arises due to regulatory inspections and internal/customer audits.
6. Handling and performing of self-inspections
7. Gap assessment of newly / updated regulatory guidance and regulatory observations.
8. Should have Knowledge or work experience of Microbial and sterile processing