To maintain the microbiology lab in accordance with GMP system.
To raise requisition for resources relevant to microbiology lab.
To perform efficient/reliable microbial testing in accordance with USP/USP-NF/EP/JP or customer guidelines.
Testing may include microbial parameters in water, product contact surface environmental monitoring,
viable air monitoring, and Microbial Limits Tests, Pathogens as well as BET test in raw materials and finished goods
To check, review and approval of microbiological results.
To schedule daily tasks in an organized and efficient manner with minimum directive.
To review, revise and/or write microbiology test methods and prepare all SOPs related to micro department.
To prepare and perform microbiological test method validation protocols and summary reports like,
Gowning validation, Disinfectant validation withhold time study, MLT method validation, BET method validation etc.
To prepare and perform microbiological validation protocols, IQ/OQ/ PQ, and summary reports for all instruments like Autoclave, Incubator, and LAF etc.
To lead investigations involving microbiological out of specification results.
To train new microbiologists on SOPs and test methods and serve as a role model.
To ensure calibration and maintain microbiology lab equipment.
Responsible for a clean, hygienic and safe working environment
To impart training as per training calendar.
Involvement in Audit and NC compliance with their record.
Awareness and get intervention through reliable sources for any changes / revision in microbiology related documents / MOA.
Responsible for resource requirement indent.
To respond to customer query and documentation.
Responsible for aqua water testing kit.
Responsible for new product development of Probiotics preparation in large scale work with outside agency.
Comply with applicable environmental, health and safety laws and regulations, company policy, and accepted safe work practices.
