 RESPONSIBLE FOR COMPLIANCE WITH THE COMPANY SYSTEMS AND PROCEDURES. TO PERFORM ADDICTIONAL TESTING IF REQUIRED IN THE DEPARTMENT, ASSIST IN COORDINATION OF DAILY ACTIVITIES IN THE MICROBIOLOGY LABORATORY. TO INITIATE, INVESTIGATE AND CLOSURE OF NON CONFORMANCES AND INVESTIGATION OF OOS TO AID IN DETERMINING ROOT CAUSES.  TO PROVIDE TRAINING ON SOPS & OTHER QUALITY DOC TO ANALYSTS IN MICROBIOLOGY LABORATORY SUPPORT QA, QC, PDL, VALIDATION FOR  MICROBIOLOGICAL ANALYSIS CO-ORDINATION FOR INTERNAL EXTERNAL AUDITS & FOR ENSURING COMPLIANCE. PERFORMO VALIDATION STUDIES ON ANTIBIOTICS AS PER USP/ BP/ IPO VALIDATION OF GEL-CLOT ASSAY [LAL] AS PER USPO VALIDATION/ QUALIFICATION, MAINTENANCE, UPKEEP & RELATED  DOCUMENTATION FOR THE MICRO LAB EQUIPMENTS (AUTOCLAVES, INCUBATORS, LAF’S, ETC.) AND CULTURE MAINTENANCE. VALIDATION/ QUALIFICATION AND PERIODIC MONITORING OF DIRECT IMPACT UTILITIES/SYSTEM E.G HVAC SYSTEM (ENVIRONMENT MONITORING), PURIFIED WATER SYSTEM, DECONTAMINATION EQUIPMENT (AUTOCLAVE). ETC AND THEIR PERIODIC TRENDING AND RECORD MAINTANENCE. CLEANING & SANITIZATION PROCESS VALIDATIONS AND ITS ROUTINE MICROBIOLOGICAL MONITORING. AREA MONITORING (GMP AREAS) FOR BIO-BURDENS. QUALITY SYSTEM DOCUMENT PREPARATION & CONTROL (SOP, STM, ETC) ALL TIME READINESS FOR COMPLIANCE AUDITS. CONDUCTING MICRO AUDITS AND DRIVING IMPROVEMENTS TO ACHIEVE MICROBIOLOGY PROCESSES. ENSURE TIMELY ANALYSIS & RELEASE OF REPORTS TO CLIENTS. COORDIATE & PRIORITISE SAMPLE TESTING IN COORDINATION WITH ANALYTICAL PRIORITIES. CONDUCT WORK PLANNING AND ALLOTMENT TO QC-MICROBIOLOGY LABORATORY ANALYSIS AND ALL INVESTIGATION OF MICROBIOLOGY DETAILS. CAPABLE OF PERFORMING ANY PROBLEM SOLVING AT ALL LEVELS AND TAKING INITIATIVE RESPONSIBILITY, EFFICIENT AT ORAL & WRITTEN AND COMMUNICATION SKILLS MICROBIAL LIMIT TESTS: GEL CLOT ASSAY AND BET VALIDATIONS: STERILITY TESTS ANTIBIOTICS ASSAYS BY DIFFERENT METHODS:A. WELLPLATE METHOD.B. TURBIDOMETRIC METHOD.

 DEPARTMENT IN CHARGE FOR – MICROBIO LABORATORY, ISO 9001 CERTIFIED FROM 2009, ALL ANALYSIS IS DONE USING STANDARD PROCEDURES THEIR VALIDATION AND TRACEBILITY PRIMARY RESPONSIBILITIES INCLUDED TESTING AND EVALUATING (AS PER QC PROCEDURES) DRUGS, FOOD, COSMETICS, PROBIOTICS & VARIOUS OTHER SAMPLES AS PER USP, BP & EUROPEAN PHARMACOPOEIAS. O CARRYING OUT FOOD AND DRUG TESTING METHODS SUCH AS:A. ANTIMICROBIAL PRESERVATIVE EFFECTIVENESS TESTS: AS PER USP & BP.B. MICROBIAL LIMIT TESTS: FOR SELECTIVE PATHOGENIC AND NON-PATHOGENIC BACTERIAL AND FUNGAL ENUMERATION AND ESTIMATION IN DRUGS, FOOD AND WATER.C. STERILITY TESTS (MEMBRANE FILTER TECHNIQUE) USING SARTORIUS OR MILLIPORE MEMBRANE FILTER. TESTS WERE PERFORMED FOR ALL INJECTABLES, PURIFIED COTTON, GAUZE, SURGICAL DRESSINGS, SUTURES AND DEVICES (STERILISED).D. ASSAYS BY DIFFERENT METHODS: WELL PLATE METHOD. TURBIDOMETRIC METHODO WELL VERSED WITH USING ASEPTIC TECHNIQUE, SERIAL DILUTIONS, PLATE COUNTING, MEDIA PREPARATION AND AUTOCLAVING, PREPARING SLANT CULTURE TUBES, STREAK AND POUR PLATING SAMPLES AND SUB-CULTURING OF MICROBIAL CULTURES.O IDENTIFICATION OF BACTERIA USING GENERAL STAINING TECHNIQUES, FUNGAL STAINING WITH LACTO PHENOL COTTON BLUE, AND GRAM STAINING.O RESPONSIBLE FOR PERFORMING MICROBIOLOGICAL ANALYSIS ON RAW MATERIALS, FINISHED GOODS, AND VARIOUS SAMPLES A. CARRYING OUT MICROBIOLOGICAL TESTING OF VARIOUS AIR, WATER AND FOOD SAMPLESB. CARRYING OUT BIOCHEMICAL TESTING FOR DETECTION AND IDENTIFICATION OF MICROBESC. PERFORMING MICROBIAL ASSAY OF ANTIBIOTICS BY DIFFUSION METHODD. ISOLATION OF ANTIBIOTIC RESISTANT MICROBES FROM WATER, FOOD AND SOIL SAMPLESE. DETERMINATION OF CELL SIZE OF MICROORGANISMSF. CARRYING OUT ANTIBIOTICS SENSITIVITY TESTS.O WELL VERSED WITH MIC TESTS, LAL TESTS (GEL CLOT METHODS), MICROBIAL LIMIT TESTS, PRESERVATIVE TESTS OR CHALLENGE TESTS, ETC QUALITY SYSTEM DOCUMENT PREPARATION & CONTROL (SOP, STM, ETC)

 GRAM STAINING & IDENTIFICATION OF BACTERIA AS PER SOP – E COLI, SALMONELLA SPP, SHIGELLA, P AERUGINOSA, S AUREUS, C ALBICANS, CLOSTRIDIA SPP & VIBREO SPP. HANDLING & TRANSFER OF CULTURES BY USING ASEPTIC TECHNIQUES ANTIBIOTIC SENSITIVITY TESTS BY AGAR WELL DIFFUSION METHOD PERFORMING ASSAYS & MIC TESTS. PERFORMING TVC TEST FOR DIFFERENT SAMPLES, IDENTIFICATION & ESTIMATIONS FOR BACTERIA & FUNGI OBTAINED FROM THE VARIOUS SAMPLES. DETECTION OF DIFFERENT PATHOGENS IN SAMPLES USING VARIOUS SELECTIVE MEDIAS  COUNTING BACTERIAL & FUNGAL COLONIES IN THE SAMPLE PLATES & REPORTING IT. PREPARING REPORTS AS PER CLIENT SPECIFICATIONS. MAKING LIST OF SUPPLIERS & LAB ADMIN DOCUMENTS USING READYMADE MEDIAS LIKE BLOOD & CHOCOLATE AGAR  USING INSTRUMENTS AS PER SOP: STANDARD WEIGHT BOX, AIR SAMPLER DEVICE, FREEZER, WATER BATH, VERNIER CALIPER, COLORIMETER, BOD INCUBATOR, INCUBATOR, COLONY COUNTER, DIGITAL PH METER, VORTEX SHAKER & CENTRIFUGE, GLASS THERMOMETER.

 GRAM STAINING LEARNING GRAM POSITIVE & GRAM NEGATIVE BACTERIA. STAINING YEAST & FUNGUS USING SINGLE STAINS. LEARNING GENERAL & SELECTIVE MEDIAS PREPARATION OF DEHYDRATED GENERAL & SELECTIVE MICROBIOLOGY MEDIAS WRAPPING GLASS PLATES FOR STERILIZATION IN AUTOCLAVES. STERILIZATION OF DIFFERENT MEDIAS STREAKING CULTURE ON AGAR PLATES CULTURE ISOLATION TECHNIQUES ASEPTIC TECHNIQUES USING INSTRUMENTS AS PER SOP: MICROSCOPE, AUTOCLAVE, LAMINAR AIR FLOW, BIOSAFETY CABINETS & WEIGHING BALANCE.