Executive
Pfizer
Total years of experience :11 years, 11 Months
Responsible for MLT validation, Finished product, In Process sample analysis, Cleaning validation and Disinfectant efficacy study.
Responsible for Sterility, BET, MLT validation and verification of finished products.
Performing microbial analysis of Swab samples, Raw water, Potable water, Purified water and Water for injection, compressed gas.
Responsible for growth promotion test (GPT) for the newly received media.
Environmental monitoring in Static and Dynamic condition. (Swab test and surface monitoring and personal monitoring, settling plate, Air sampler techniques).
Preparation of SOP, Validation procedures, General testing procedures, Protocols, Summary reports and Environmental monitoring trends.
Responsible for preparation of Validation protocol, SOP, General testing procedures, Validation reports, Logbook formats.
Review of logbooks, test reports, raw data, online documentation and regulatory compliance of laboratory.
Testing and release of BET testing of water samples, raw materials, In process / Finished and Stability samples and Validation samples.
Responsible for testing and validation of Finished and stability samples Sterility test by Open and Closed method.
Responsible for indent inventory control of BET reagents and perform confirmation of labelled claim sensitivity of Lysate upon receipt.
Responsible for testing, validation and release of MLT of Raw materials / Finished / Water analysis and Stability samples.
Cleaning validation, Swab sample analysis, disinfectant validation.
Responsible for handling of LIMS.
Responsible for all EHS related and Hazard identification.
Responsible for Laboratory environmental monitoring via Passive, Active and Surface monitoring.
Responsible to monitor and ensure Laboratory Cleaning and monitoring of temperature and Humidity, Differential pressure, UV Lamb usage, etc.,
Responsible to perform BET routine analysis, MLT & AET method validation, verification and routine analysis, STERILITY open and closed method for API, formulated products, medical devices as per pharmacopeia, client approved protocols.
Involving operations using Hot air oven, Incubator, Balance, pH meter, Autoclave, Micropipette, LAF etc.,
Responsible for culture maintenance and culture suspension preparation.
Receiving and performing growth promotion testing of incoming lots of microbiological media and media preparation for routine analysis.
Responsible for Microbiological environmental monitoring of clean classified areas (Passive and Active monitoring) by Settle Plate, Air Sampling, Contact Plate methods.
Responsible for daily monitoring of Temperature and Relative Humidity, Differential pressures, daily calibrations.
Responsible to maintain the cleanliness of microbiology laboratory.
Responsible to carry out preventive maintenance of equipments, GMP documentation.
Involved in enzyme assays and Probiotic analysis.
Media Preparation and optimization.
Culture maintenance- Glycerol stock preparation, Seed Inoculums preparation.
Fermenter sample analysis and guide the production team about harvesting.
Product quality checking and Product Stability analysis.
Shake flask study to enhance the production.
Responsible for Calibration and maintenance of analytical equipments.
ISO Documentation.
❖ B.Tech Biotechnology from Anna University of technology, Tirunelveli, 2012, (87.8%)
INPLANT TRAINING: Participated in the science city, Government of Tamilnadu sponsored summer training programme on “Advanced molecular techniques in Biological sciences” held at the centre for advanced studies in botany, University of Madras, Chennai, India from 8th to 28th May 2012. Attended 5 days training on “Quality Control and Management” in Aavin dairy products Ltd at Madurai. PROJECT SNAPSHOT ( Under graduation) Title : Molecular identification, Antibiotic susceptibility and Molecular docking studies on Staphylococcus hominis In Dept of Bioinformatics at Alagappa University, Karaikudi. CO-CURRICULAR ACTIVITIES: Passed British English Certificate Preliminary Exam conducted by University of Cambridge ESOL Examinations. EXTRACURRICULAR ACTIVITIES: Presented a paper on “Biosorption” organized by Cybrog2k11” at P.R. Engineering College, Thanjavur. Presented a paper on “Biofuel” organized by Computer society of India, Innova’09 at P.S.R Engineering College, Sivakasi. Participated in a “Seminar on Biotechnology” organized jointly by British Council and Anna university-Chennai, Participated in the technical symposium and seminar Attended a two days workshop on “Emerging Trends in Green chemistry” at Adhiyamaan college of Engineering, Hosur.
❖ HSC from MC higher secondary school, Madurai, 2007, (78.3%)