Quality Control Maintenance

CURRICULUM VITAE

Amit M.Dange

Plot no *, Dwarkapuri, Rameshwari

Post bhagwan nagar

Nagpur (MH) India, Pin-440027

E-mail:****.*******@*****.***

Contact No.:+91-800*******, +91-954*******

OBJECTIVE:

Seeking a challenging and rewarding opportunity with an organization of

repute which recognizes & utilizes my true potential while nurturing my

analytical and technical skills in the field of Biotechnology, Microbiology

Synopsis:

< A result driven professional with nearly 4 years of experience in the

area of Quality Control as a Microbiologist.

< Presently working in Perfect Industries Private Limited(ISO 22000) as a

Lab-In charge in Microbiology department (Established Microbiology lab

with GMP and GLP Facility)

< Worked at KUMAR ORGANIC PRODUCTS LIMITED BANGALORE, BIO-TECH R&D CENTRE

(USFDA Approved Facility Company) as a R&D Microbiologist.

< Develop Quality processes according to product, Standardized product

analysis with quality plan and maintain quality standards. Handling

Customer support and complaints.

< Adept at Microbial limit test as per USP, EP,IP Environmental monitoring,

Water analysis (DM,RO,PROCESS WATER), labeling, Culture Maintenance(ATCC

& MTCC), Pathogen testing(contaminants), Fermenter, Microbial

fermentation, strain development, RT-PCR, Detection of GMO and non

GMO,ELISA, Electrophoresis, DNA extraction,, Shake flask fermentation,

Downstream, filtration Inoculum, Bioburden test, swab test, Media

inventory(stock),Growth Promotion test, Sterilization, De-contamination,

Biological indicators, sterility testing, Antibiotic sensitivity test,

Method Validation, Clean room validation, MSDS, autoclave validation,

QMS, IQ,OQ,PQ of lab instruments, Document up gradation as per audits and

certification.

< Successfully faced Audits conducted by USFDA, and ISO.

< Set-up for performing gram staining. Prepares, labels and dispenses

reagent and media, Perform biochemical reactions; identify micro-

organisms; interpret tests and quality control results

< Assists in the stocking, ordering, receiving, and distribution of

supplies. Good experience at handling and Calibration and validation of

Laboratory Instruments.

< Comprehensive knowledge in quality check of raw materials, in process

checks, intermediate and finished products.

< Review of all documents related to USFDA, HACCP, GMP, Kosher, Halal, GLP

and ISO22000, Knowledge of Regulatory affairs.

Professional Experience:

. Presently working in Perfect Industries Pvt ltd. (Nagpur) as a Lab-In

charge in

Microbiology Department NOV 2012 to Till Date

. Kumar Organic Products Limited, Bangalore QC-Executive

(Microbiologist)

DEC 2009 TO NOV 2012

Academic Qualification

2009 Master's Degree in Biotechnology from MVJ College, Bangalore

University, Karnataka.

2007 Bachelors Degree in Biotechnology from G.H Raisoni College Nagpur,

Raipur University.

Technical skills

. Molecular Biology Techniques

. Isolation of DNA, RNA from given sample

. Identification of novel micro-organisms(Bacteria, Yeast, Fungi)

Additional Qualification

A+ Certified Diploma in "RECOMBINANT DNA TECHNOLOGY" from Disha Institute

of Biotechnology, Nagpur (Branch of Best Biotech Research Labs, Bangalore)

Analytical

. Responsible for the monitoring of the manufacturing facilities for air

& water quality

. Bio burden determination of raw materials and final products

. Perform data analysis & generate analytical reports

. Culture Maintenance and documentation.

. Operation, maintenance, Calibration and troubleshooting of the

instruments and maintaining records of the same.

. Handling root cause analysis, CAPA, incident reporting, OOS results.

. Studying comparative Anti-microbial activity, Efficacy of Products,

preservatives (MIC)

Other skills

. Train other associate for training, testing, support system and

products.

. Successfully faced US FDA Audit in the month of March, 2011

. Assisted in developing and standardizing manufacturing methods.

. Literature Survey for R&D Process-Update with current scientific

literature to select methods and techniques for research

Strengths

. Achievement oriented with excellent ability to manage, change with

ease

. Strong communication interpersonal learning and organizing skills

. Team work with Good Managing capacity

Personal Details

Date of Birth : 19.08.1984

Marital status : Unmarried

Languages known : English, Hindi, Marathi

Passport Number : G4522013

I hereby declare that all the information stated above is genuine to the

best of my knowledge.

Amit M.Dange

Date:

Place: NAGPUR(MH) INDIA

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