Microbiology, Jr. Manager, Validation, SOP preparation, QMS

CURRICULUM VITAE

Amit V. Shirsat

D***, Swanand Shaphire

Behind HP petrol Pump,

Katrap, Badlapur(E)

Mumbai-421503

Objective:-

To work with Progressive Organization that gives me scope to use my skills and creativity in accordance with the latest technologies and need of the market.

Seeking a challenging position in the field of Biotechnology, pharma and Life Science in a Good Organization, where in, I can utilize my Technical skills and Interpersonal relations for achieving the goal and objectives of the organization and my profession.

Work Experience:-

Pitambari Products Pvt.Ltd.

Position: Jr. Manager Microbiology Dept

Job Profile:

1.Ensures compliance with current procedures, specifications and methods.

2.Maintains accurate records of test results and issues reports as required.

3.Performs and/or manages air, water, and environmental sampling.

4.Performs and/or manages microorganism identification on environmental, water and product isolates. Maintain accurate records on all isolates.

5.Performs and/or manages preservative efficacy testing with outside laboratory as appropriate and recording of results.

6.Responsible for alerting senior member of management of potential problems in the areas of quality control.

7.Manage training and development of personnel assigned, continually encouraging 100% employee engagement (if applicable).

8.Analyze and report on bulk, raw material, and finished goods.

9.Analyze and report status on quality incidents, raw material, bulk, and finished good non-conformances. Conducts OOS investigations.

10.Develop quality trends based on analysis of waivers and non-conformances. Identifies plan for improvements.

11.Develop training and train laboratory personnel on the use of new test methods and equipment.

12.Troubleshoot equipment and methods and communicate with vendors and outside contract testing laboratories.

13.Provide support, if necessary, to the analysis of raw material, In process and finished good samples, culture media preparation, stock culture maintenance, water sampling/testing, microbial identification and laboratory housekeeping/cleaning.

14.Involvement and follow up on the corrective action process.

15.Purchase and implement new test equipment for the Industrial Quality Laboratories.

16.Manage and enforce the compliance to ISO, GMPs, FDA regulations.

17.Leads a team of professionals and technicians, continually encouraging 100% employee engagement.

18.Carry out all duties in accordance with Good Laboratory Practices.

Tenure: May 2014 To Till Date.

ROHA DYECHEM PVT.LTD. Roha, Dist: Raigad

Company Profile:

Roha Dyechem. Pvt. Ltd. is one of the world’s largest manufacturers of synthetic & Natural food color. Company is having a global presence in more than 100 countries over 6 continents with offices, manufacturing facilities and laboratories in 13 countries. Products conform to UN food & agriculture organization requirements & regulatory requirements like FDA, EU, & WHO Specification & Kosher & Halal Certifiable products.

Position: Sr.Microbiologist

Job Profile:

1.Conduct Microbial Limit Tests (MLT) of Raw Materials, Finished Products and water.

2.Environment monitoring by swab analysis, settling plate method.

3.Performing Growth Promotion Test for incoming culture media and ready media plates.

4.Maintaining microbial cultures in passages periodically as per the stipulated Scheme.

5.Supervising autoclave cycles as per the requirement.

6.Performing Disinfectant Efficacy Test for different types of disinfectants used in the laboratory.

7.Preparing and updating QC related SOPs and Test Data Sheets

8.Receiving and maintenance of dehydrated media and media preparation as per operating procedure.

9.Operation and documentation of laboratory instruments.

Tenure: May 2009 To April 2014

AARTI DRUGS LTD. Sarigam, Gujrat

Company Profile:

The manufacturing-units of ADL are GMP certified. The Company is also in the process of acquiring an ISO 9002 compliance for all its units, Since its inception, the Company has established a strong presence in the Anti-diarrhea, Anti-inflammatory therapeutic groups. With its manufacturing facilities at Tarapur and Sarigam, the Company manufactures Vitamins, Anti-arthritis, Anti-fungal, Antibiotics, ACE inhibitors, besides its range in, anti-diabetic, anti-cholinergic, sedatives and anti-depressant drugs.

Position: Microbiologist

Job Profile:

1.Sampling and performing MLT testing of Row material, in process, Packed and finish products as per IP, BP, and USP.

2.Conduct Microbial Limit Tests (MLT) of Raw Materials, Finished products and Water Systems.

3.Bacterial Culture Maintenance.

4.Discarding of Media and Cultures and conduct sterilization of materials By Autoclaving and operating Dry Heat Sterilizer (DHS).

5.Preparation of specific Culture Media required for different tests.

6.Microbiological Monitoring of Environment in Sterile Production

7.Area which includes Plate Exposure.

Tenure: Nov 2007 to Dec 2009.

SUNWAYS Laboratories Pvt. Ltd. Sarigam, Gujarat

Company Profile:

SUNWAYS (INDIA) PVT. LTD. Have their own sterile products manufacturing plant at Goregaon, Mumbai, where specialty products in ophthalmic formulations are being manufactured for last 30 years under the technical supervision of experts in production and quality assurance

Position: officer Microbiologist

Job Profile:

1.Test the Yeast & Mould, Total Plate Counts and pathogens.

2.Log book maintenance

3.Record keeping of samples.

4.Up keep of environment records daily.

5.Preparation of media.

6.To confirm yeast & mould by microscope.

7.Maintenance & up keeping incubators.

8.Prepare tests reports.

Tenure: From Dec 2006 to Nov 2007

KEY STRENGTHS

Professional: Meticulous Team player Quick learner Result Oriented Studious Adaptive to New technologies and systems

Personal Details:-

Name : Amit V. Shirsat

Gender : Male

Date of Birth : 19th Aug. 1982

Permanent Address : C/o V.J. Shirsat

Kothari Vatika no.3, Malkapur, Akola. (M.S)

Nationality : Indian.

Passport No. : J9738855

Languages (R/W/S) : English. Marathi and Hindi

E-Mail : ****************@******.***

Mob : +91-823*-******

Academics:-

Course

YEAR

College/University

Class

M.Sc.

(Biotechnology)

2007

S.R.T. University, Nanded

Second

B.Sc.

(Microbiology)

2004

Amravati University

Second

H.S.C.

2001

Amravati University

Second

S.S.C.

1998

Amravati University

Second

Computer Skills:-

Successfully completed MS-CIT

Proficient with Ms-office, Ms Access, conversant with Windows and Data base operating.

Research Experience:

M. Sc. Dissertation:

1) “Antibacterial activity of cow urine distillate on few Bacteria”

The Cow urine (Gomutra) is known as a medicine use since a long time in India. Many use full element have been found in cow urine, which has antimicrobial activity. In study it was observed that cow urine distillate shows more inhibitory effect where observe on few bacterial pathogens.

Other Activities:-

1)Participated in “Volleyball Championship” in Inter College.

2)Participated in seminar on Microbiology held in R.L.T. Science College.

Declaration:-

I declare that all the above information and statement are true to the best of my knowledge.

Amit Vishnu Shirsat

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