Deviation and Contamination Investigations: Manage a wide variety of quality and manufacturing deviations. The core focus will be on directing investigations related to out-of-limit Environmental Monitoring (particulate and microbiological), non-conformities in sterility or bioburden tests, and behavioral or gowning deviations in classified areas (Grades A, B, C, D).
Advanced Root Cause Analysis (RCA): Conduct in-depth root cause analyses for events linked to potential asepsis breaches or general process non-conformities, working closely with Production, Microbiology/Quality Control, and Engineering departments.
CAPA Management: Identify, implement, and verify the effectiveness of Corrective and Preventive Actions (CAPAs) to prevent the recurrence of contamination events and other quality discrepancies.
GMP and Annex 1 Compliance: Ensure the alignment of all manufacturing and control procedures for injectable drugs with current cGMP regulations for sterile products).
Document and Procedure Management: Draft and review operating SOPs and working instructions
Training and Quality Culture: Promote and support the training of personnel operating in production departments.
