Manager Compliance - Sterile

Position - Manager Compliance
Experience - 14+ years With Microbial and sterile processing
Qualification - MSc / B.Pharm / M.pharm
Job Description

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