Microbiologist @Nipa Pharmaceuticals Ltd.

Job Responsibilities

• Perform sampling and microbial testing of Raw Materials, finished products, water and ETP as per written procedure.
• Identify and isolate pathogenic microorganism in solvents & products.
• Perform settle plate count in dispensing, processing and primary packaging areas.
• Determine total coliforms in water.
• Perform bioload tests in clean areas.
• Perform IPC activities in every step of manufacturing and implement cGMP regulations.
• Preparation and updating of SOPs, specifications and methods for raw material, water and finished products etc.
• Prepare SOP for all instruments of Microbiology Department.
• Perform the operation, Qualification, Calibration and Validation of microbiological instruments.
• Prepare and preserve media as per compendia.
• Perform Environment monitoring as per requirement.
• Monitor, control & maintain records of hygiene for Microbiology, Warehouse & Production Department.
• Review, evaluate and make recommendations regarding microbiological hazards on manufacturing facilities, processes,
• equipment, packing, testing laboratories, materials, that have impact on microbial quality of pharmaceuticals.
• Neutralize antimicrobial properties in products.
• Perform sterility tests by both membrane filtration and direct inoculation method.
• Perform microbial limit tests.
• Perform microbial tests and release from user end point for production.
• Establish microbial alert and action level within process and product specifications.
• Perform antimicrobial effectiveness testing.
• Perform colony count tests.
• Perform BIOASSAYS.
• Determine whether enforcement actions and compliance policies incorporate sound scientific and technical information.
• Train Production, Housekeeping and Warehouse people with respect to microbiological point of view.
• Review and evaluate regulatory action submission focusing on Good Manufacturing Practice (GMP) violations.
• Evaluate evidence and inspection narratives to determine microbial risks.
• Check sterile production areas daily.
• Check all people in Production area daily with respect to microbiological point of view.
• Incorporate fundamental knowledge of the intended use of a product when evaluating risks, based on understanding of the patient populations taking a drug and their susceptibility to infection.
• Apply new developments and theories to novel problems or potential public health threats for which guidance does not currently exist.
• Meet with stakeholders to exchange information and to provide advice and guidance.