Role & responsibilities
Lead end-to-end Microbiology Laboratory and Process Microbiology operations.
Manage Environmental Monitoring (EM), personnel monitoring, water monitoring, sterility testing, BET and microbiological testing.
Drive Contamination Control Strategy (CCS) and microbiological risk management across sterile operations.
Lead investigations related to EM excursions, deviations, OOS/OOT, failures and CAPA.
Ensure readiness and represent Microbiology during USFDA, EU-GMP and customer/regulatory audits.
Review/approve SOPs, protocols, validation/qualification documents, investigations and microbiology reports.
Oversee Media Fill/APS, method validation, area qualification and microbiological risk assessments.
Lead implementation and effective utilization of LIMS, EM and other digital systems.
Manage, mentor and develop a 60+ member Microbiology team, including manpower planning, training and competency development.
Collaborate with QA, Production, QC, Engineering, Validation and Regulatory teams for compliance and operational excellence.
Drive continuous improvement, laboratory efficiency, digitalization and microbiology best practices.