Mitesh Amin

E-mail : p5np8q@r.postjobfree.com

Cell :- 848-***-****

Objective : Looking for a challenging position in the field of Diagnostic, Pharmaceuticals and Bio-Technology, which offers a valuable experience and opportunity for advancement.

Summary: Experience as a Microbiologist and Analyst of total 14 + years. Also attend the training

program of Basics of Computer and Basics of HPLC Instruments, testing by this instruments.

Experience of doing testing accordingly ISO and FDA Standards.

Work Experience

Microbiologist (QA Associates) ( 05/2008 – 05/2010 )

Johnson & Johnson (Kelly)

• Perform all types of water testing like tap water, distilled water, WFI as per USP.

• LAL testing of WFI, Distilled water and finished product by gel clot method. Also doing water by turbidometric method.

• Product Bio-burden testing like Red cell, Anti sera, bio-vue cassettes, raw materials by membrane filtration technique.

• Environment monitoring in different class with contact plate method, Viable Air sampling using SAS air sampler and Non viable Air sampling using Met One.

• Samples log in, results entry, release in LIMS, LMS.

Machine Operator

International Technidyne Corporation, Edison, NJ. ( 01/2008 – 04/2008 )

• Filling operator and Machine filling products cuvettes

• Maintaining & updates the Batch Manufacturing Records.

• Machine operator like – Labeling Machine, Taping Machine.

• 100 % filling and Labeling Inspections.

Microbiologist (Microbiology Section)

Farmson Analgesics,Nandesari, Baroda, India ( 04/2004 – 08/2007 )

• Perform the raw material testing in Micro and Chemistry as per IP, BP, USP.

• Water testing, Pathogen testing.

• Environment testing, Including validation of various Class according to HEPA filters.

• Validation and calibration of Autoclave.

• HPLC testing of product and raw materials as per IP, BP and USP.

• Preparation of SOP and Batch Manufacturing Records.

• Preparation of document for certification like cGMP, cGLP, ISO, EDQM and WHO.

Senior Microbiologist

Elysium Pharmaceutical Pvt Ltd, Dabhasa, Baroda , India ( 08/2002 – 03/2004 )

Work Experience :

• Perform and review the results of raw materials, in process testing and finish product, LAL of water and products also

• Perform and review the results of Sterility testing, parental department’s environmental testing, air monitoring.

• Preparing sanitization program for weekly basis.

• Perform and review the antibiotic assay, vitamin assay by cylinder cup method, toxicity test.

Production Supervisor

Grace BioCare Pvt Ltd., Manjusar G.I.D.C., Baroda, India ( 07/2000 – 08/2002 )

• Prepare the production schedule of Bio-pesticide by fermentation.

• Handle the production, laboratory both with man powers.

• Total six different types of products.

• Reports to Director of company.

Microbiologist

M. J. Institute of Research, Baroda, India (01/1998 – 07/2000)

• Perform the testing of raw materials, and finish product.

• Perform the LAL product and water also.

• Perform the Sterility testing, Department’s environmental testing, air monitoring and also doing sanitization of sterility room.

• Daily basis Antibiotic assays, vitamin assay by cup method.

• Pyrogen tests for different products.

• Oxytocin assay by bio-assay with live tissue.

• Perform toxicity tests.

• Perform the comparison of different antibacterial soap’s activity against different 21 species of bacteria by multiwall plate and on human’s real skin.

Microbiologist + Production supervisor.

Agriland Biotech Pvt. Ltd., Baroda, India (08/1995 – 01/1998)

Work Experience :

• Perform the fermentation, experiments for new products.

• Perform and review of product’s results on field and laboratory both.

• Production of Mushroom’s seed in lab and actual production of mushroom in lab also.

Education:

• Post Graduate Diploma in Medical Laboratory Technician – April 1994 (GSMLT, India )

• Bachelor of Science in Microbiology – April 1993-1994 (S.P.University, India)

Certificates :

• Approved Microbiologist of Food and Drug Administrative (FDA) Depart. of GUJARAT, INDIA

• Basics of HPLC Training

• Diploma in Computer Application.

Computer Skills:

• Proficiency in Microsoft Word, Excel and Power Point

• Familiarity with Programming Languages: C++/C,

Instrumentation:

• Microscopic Examination, ThermoMax Plate Reader for Endotoxin test, HPLC,UV Spectrophotometer, TOC Analyzer, pH-meter, Viscometer, Centrifuges, various types incubators, various types of shakers, humidity controllers, colony counter and ovens.

Mitesh Amin

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