MANAGER / SENIOR MANAGER – MICROBIOLOGY (QC)

Job title: manager / senior manager – microbiology (qc) location: indore – regulated pharma manufacturing plant department: quality control – microbiology reporting to: head – quality control job type: full-time | managerial level job purpose
to lead the microbiology function in the qc department, ensuring compliance with current good manufacturing practices (cgmp), regulatory requirements (usfda, eu-gmp, mhra, who, etc.), and company quality standards by overseeing microbiological testing, environmental monitoring, sterility assurance, and microbiological risk assessments. key responsibilities
leadership & team management
lead and manage the microbiology team, ensuring training, development, and performance management. provide technical guidance to resolve complex microbiological issues. compliance & regulatory readiness
ensure strict adherence to cgmp , glp , and data integrity principles in all microbiological activities. prepare and face regulatory inspections (usfda, mhra, eu, who-gmp) and ensure readiness through gap analysis and internal audits. microbiological testing oversight
supervise and review all microbiological testing activities including
environmental monitoring (em)
water testing (wfi, pw, hvac, compressed air)
sterility testing and bacterial endotoxin testing (bet)
microbial limit tests (mlt)
bioburden & identification of isolates
disinfectant effectiveness studies and media growth promotion testing
documentation & quality systems
review and approv...