Manager/Senior Manager-R&D Cum QC Microbiology

ROLES & RESPONSIBILITIES:

• Monitor sampling and testing as required for environmental and personnel monitoring, samples of raw materials, in-process product, and finished product.
• Monitor quantitative and qualitative microbiological tests such as for media controls,

enumeration, sterility testing, absence of index organisms, classification and specification,

antimicrobial effectiveness, etc. performed by all QC Microbiology personnel.

• Trains and qualifies personnel for Aseptic Operations, Microbiological Sampling and Testing, and associated documentation.
• Trains Microbiologists, assigns tasks, monitors their performance, and reviews their testing and documentation.
• Reviews Laboratory Notebooks and Logs as detailed in applicable procedures.
• Monitor calibration checks and performance checks of instrumentation and devices.
• Provides support for all testing, tasks, and documentation in support of Validation Studies

including Process Validation, Media Fills, Method Validation, and development of analytical methods.

• Responsible for participation in plant audits.
• Functions as a technical advisor and problem solver for Microbiology related issues.
• Participates in cross-training in QA and QC areas of responsibility.
• Performs other duties as assigned or required.
• Research and development of new microbiological media, and research on existing microbiological media for betterment of growth of specific microorganisms.