Role Summary
The Assistant Manager – QC Microbiology oversees microbiological testing operations to ensure product safety, regulatory compliance, and laboratory efficiency. This role involves supervising lab personnel, validating test methods, managing documentation, and supporting audits and investigations.
Key Responsibilities
- Supervise daily microbiological testing of raw materials, in-process samples, and finished products
- Ensure compliance with GMP, GLP, and regulatory standards (e.g., FDA, WHO, ISO)
- Review and approve test reports, deviations, and CAPAs
- Oversee environmental monitoring, water testing, and cleanroom validations
- Manage media preparation, sterility checks, and microbial identification protocols
- Coordinate with cross-functional teams during investigations and audits
- Train and mentor junior microbiologists and lab technicians
- Maintain and update SOPs, logbooks, and equipment calibration records
Qualifications
M.Sc. in Microbiology, Biotechnology, or related field5–8 years of experience in QC Microbiology, with at least 2 years in a supervisory roleStrong understanding of aseptic techniques, contamination control, and regulatory guidelinesProficiency in microbial identification, endotoxin testing, and rapid microbiological methodsExperience with LIMS and electronic documentation systemsDesired Skills
Leadership and team managementAnalytical thinking and problem-solvingAudit readiness and documentation controlExcellent communication and interpersonal skills