Description
ARCHANA NATHU TAMBE
405, Krishna-Kunj CHS, Rambaug main Road, Kalyan (West) – 421301
Contact No. +919867875029; Email : archanantambe@gmail.com
MICROBIOLOGIST FDA APPROVED IN MICROBIOLOGY & STERILITY (Sr. QUALITY CONTROL EXECUTIVE) – PHARMACEUTICAL INDUSTRY
Seeking challenging assignments across the Industry
EXECUTIVE SUMMARY
· Dedicated resourceful and innovative professional offering extensive industrial experience of over 10 years in Microbiological processes across the different industries; currently spearheading as Microbiologist (Senior Quality Executive) with MP Biomedical (India) Pvt Ltd.
· Excellent academic credentials; M.SC in Microbiology from Vinayaka University preceded by B.SC in Microbiology from Mumbai University.
· Ability to conceptualize careful & sophisticated quality control measures in compliance to the specified standards while performing root-cause analysis to prevent any reoccurrences & defective issues.
· Capable of performing a wide range of tests/ inspection procedures in conformance with the domestic and international regulatory regime; Good exposure to microbiological testing of the sterile and non-sterile formulation.
· Excellent reporting skills, outstanding success in building/ maintaining relationships with customers and colleagues. Ability to use sound decision-making skills and effectively perform in a self-directed work environment.
Calibrations & Instruments Handled:
ü Microbial Incubators.
ü BOD incubators.
ü HPLC [Agillent & Shimadzu]
ü Gas chromatography [Shimadzu & Perkin elmer & chemito]
ü Atomic absorption spectrometer [varian]
ü IR [spectra manager [Jassco]
ü Polarimeter [Jassco]
ü UV spectrophotometer [Jassco]
PROFESSIONAL DEVELOPMENT:
Key Responsibilities:
· Assuring that microbiological testing is properly performed and interpreted, monitor sanitation requirements of the plants facilities, perform environmental studies and maintain Good Laboratory Practices (GLP’s) in documentation and record-keeping.
· Assuring that appropriate test procedure are followed and that proper controls are maintained.
· Informing management of potential problems, their remedial measures and other pertinent information through oral and written communication.
· Also Preparing All Documents like SOPS, Test reports for Raw, In-Process as well as for the finished product.
· Also preparing Documents if any material is in OOS & their CAPA record.
· Performing all necessary validations related to microbiology.
· Initiating development & implementing new & improved techniques for microbiological testing and sampling.
· Maintaining and calibrating all laboratory equipment. Involved in the Validation of Microbiology lab and Documentation.
· Prepared the water validation system as per microbial methods as well as their required protocols.
· Handling the Ethylene oxide sterilization as well as did the ethylene oxide sterilization validation as per ISO11135.
· Prepared the cleaning validation as per microbial method as well as their required Protocols.
· Dexterous in conducting Chemical analysis of Raw materials, Intermediate & Finished products.
· Shouldering the onus of preparation & Standardization of Volumetric Solutions.
· Also implementing the systems in the Store department.
· As well as assist the QA manager for Batch Manufacturing Record, some QA works in cGMP,ISO 13485 & OHAS Audit as well as Customer Audits.
Microbiological Tests Performed:
· Total microbial count.
· Total fungal count.
· Test of Pathogens like:
E.coli
Salmonella
Staphylococcus aureus
Pseudomonas
Shigella
Bacillus Cereus
Vibrio cholera
Vibrio parahaemoliticus
Faecal streptococci
Enterobacteria
· Water testing [chemical & biological]
· Microbiological Assays like
Vitamin B12 (Cup plate method)
Calcium pantothenate
Folic acid
· Antibiotics Assay
Gentamycin. (Cup plate method)
Tetracycline (Cup plate method)
· Culture Maintenance.
· Bio –Burden test.
· Microbial Sterility testing.
· Particulate Matter test.
· Prebiotic & Probiotic count.
· BET testing.
· Scorched particle Test.
· Melamine testing [Qualitatively].
· Environmental Monitoring.
· Other Chemical Tests Like:
LOD, Vit. C Content, protein content by kjeldal method
· Instruments calibration Like
Spectrometer, Balance PH meter, Autoclave, Hot Air Oven, Incubators.
· Packing material testing.
Pharma Base India Pvt ltd
QA/QC Executive Microbiologist Nov 2013 to June 2018
George Philips Medical Engineering PVT ltd. Jan 2012 to Nov 2013
QC Executive Microbiologist
Bioxera Pharma Private Limited [API] Dec 2010 – Dec.2011
QC Executive Microbiologist
Pharma Base India Limited [API] Mar 2010 – Dec 2010
QC Microbiologist
Raptakos, Brett Test Laboratories Limited Jan 2005 – Feb 2010
Microbiologist
Eumark Pharmaceuticals Private Limited [WHO company], Ambernath Mar 2004 – Dec 2004
QC Microbiologist
Hemkish Chemicals Private Limited, Khairane, Navi Mumbai APR 1999
Job training of Industrial Microbiology
ANA Laboratories, Mumbai May 2000
Job training of Industrial Microbiology
ACADEMIC CREDENTIALS
M.SC in Microbiology; 2012 from Vinayaka University
B.SC in Microbiology; 2002 from Mumbai University
FDA Approved in Microbiology & Sterility
The vocational course of Industrial Microbiology; 2002 from Mumbai University
Diploma in Medical Laboratory Technology; 2003 from Bombay Paramedical Institute
MS-CIT computer Course; 2003 from Keerti Computer Institute
Swift Jyoti Computer Course; 2001 from NIIT
PROJECTS UNDERTAKEN
· Entrepreneur project on Preparation of Tomato Sauce at a small scale in industrial microbiology at T.Y.B.SC
Notice period: one Month
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DOB: 11 June, 1980; Languages Known: English, Hindi & Marathi; References: Available on Request