COVERING LETTER

Date: Monday, July **, ****

From,

Prashanth.N

S/o NaraseGowda,

#****, ********, ********* *****,

T. Dasarahalli, Bangalore – 560057, India.

Cell: +918*********, Res: +919*********.

Email: ac6hcv@r.postjobfree.com

To,

HR Department

Subject: Application for suitable position in Q.C. Microbiology/ QA Microbiology.

Dear Sir/Madam,

I have post-graduation specialization with Microbiology from Bangalore University and Post-Graduation specialization in Biotechnology from Kuvempu University and scored first class. Currently I am working as Junior Manager Microbiology in Syngene International Ltd (Biocon), Bangalore since August 2016 to till date. I have more than 09 years of versatile pharmaceutical experience in Formulation (Injectables, Ophthalmic and Oral solids) and API facility. I am very much interested to join and serve for the betterment of esteemed organization like yours.

If you are giving me a chance to accompany you, I will be very happy and I will do my duties with sincerity, honesty and fullest satisfaction. Herewith I have enclosed my curriculum vitae for your kind perusal. Hoping your positive response.

Yours Truly

Prashanth N

CURRICULUM VITAE

Enthusiastic to support organization

Key Areas:

Successfully faced USFDA Audits three times, PMDA audit one time, EMEA audit one time and TGA audit one time.

Approved Microbiologist in Karnataka.

EXPERIENCE

1.Presently working as Junior Manager at (Biocon) Syngene International Ltd. (Sterile, Non Sterile Formulation, Biologics and Chemical development), from August 2016 to till date.

2.Worked as Assistant Manager - Microbiology for Wintac Limited (Sterile Injectables and Ophthalmic), Bangalore since January 2014 to August 2016.

3.Worked as QC Senior Executive (Microbiology) for Biocon Limited, (API and Enzymes) Bangalore since October 2010 to January 2014.

4.Worked as QC Executive (Microbiology) for Wintac Limited, (Sterile Injectable and Ophthalmics) Bangalore since March 2009 to September 2010.

PROFESSIONAL SYNOPSIS

SYNGENE INTERNATIONAL LIMITED (BIOCON).

Experience: This organization is engaged in manufacturing and exporting of various sterile and non-sterile formulations. Syngene is USFDA inspected plant and have approvals of USFDA, WHO, PMDA, EUGMP and COFEPRIS (Mexico).

In my total experience in Syngene I’m exposed to various Global Costumer Audits, Handling audit and compliance for Microbiology Department, Documentation Review and preparation of SOP, EOP, Specification and method of analysis based on requirements.

Here I am responsible for leading a team of about 10 microbiologists in Quality Control microbiology laboratory and to participate in the investigation of complaints related to the quality of the product.

Time management skill and work planning ability within the group, Ability to solve the problem and decision making skills, Manpower management and utilizations of skilled manpower.

To participate in change control procedures on need basis and to initiate change controls, investigate incidents and deviations related to Microbiology aspects.

Responsible for imparting training to subordinates as per SOP and on current GMP practices.

Responsible for reporting to quality control manager on regular basis on compliance.

To submit compliance of any of the non-compliance served by audit.

Coordination, testing and reporting for all validation activity of production.

To approve or hold or reject the finished product, in process bulk, final bulk, inactive raw material or active raw material.

AHU Qualification and Equipment/ Instruments Qualification.

Area Qualification and Water Qualifications.

Preparation of method validation protocols based on regulatory requirements.

Review, approval and release of microbiology analytical data of raw materials and finished products and trend analysis.

Responsible for conducting Internal audit.

Preparation of miscellaneous validation protocols for audit compliances.

To lay down Quality Assurance system to ensure cGMP/ cGLP compliance at Plant/Quality control department as per quality standards.

Quality analysis of food and food products as per HACCP/ FSSAI.

WINTAC LIMITED

Experience: This organization is engaged in manufacturing and exporting of various sterile and Opthalamics. Wintac limited is USFDA inspected plant and have approvals of WHO, EUGMP and TGA. Training and development, conducting telecom with different costumers, here I was responsible for leading a team of about 08 microbiologists in Quality Control microbiology laboratory.

To participate and organize method validations of Bacterial Endotoxin test, Microbial Limit test, Sterility method Validation, method suitability studies.

Area Qualification for new facility and area requalification.

Hold time study protocols like Disinfectant hold time study, Depyrogenation hold time study.

Miscellaneous microbiological validation activities and process simulation studies.

To ensure that the analytical method are developed and validated as per the current regulatory norms.

Exposure to quality management system such as change control, event and deviation, corrective and preventive action (CAPA).

Review, approval and release the microbiology analytical data of sterile/ non-sterile raw materials and sterile/ non-sterile finished products,

Preparation of documents for ANDA submissions.

BIOCON LIMITED

Experience: In my total experience in Biocon limited I’m exposed to various Global Costumer Audits, Handling audit and compliance for Microbiology Department, Documentation Review, Review SOP, Instrument Calibration, AHU qualification and Equipment/ Instruments Qualification.

To prepare and implement the SOPs, protocols and specifications.

Review of the log books.

To carry out sterility testing of the product, raw material and primary packing materials.

Environmental Monitoring: Routine monitoring of controlled environment by Active, Surface sampling and personnel monitoring. Non-viable air borne particulate matter monitoring of controlled environments using airborne particle counter.

Water system: Routine analysis of potable water, purified water, water for injection for total Microbiological count and pathogens.

Media preparation: Regular preparation, sterilization, storage and utilization of the media.

Microbial limit test: Aseptic sampling of Raw Materials, water and routine analysis of MLT of Raw materials, semi-finished products, primary packing materials etc.

Maintenance of cultures: Procurement, sub-culturing (3 passages) and maintenance of cultures.

Bacterial Endotoxin test: BET by gel clot technique using LAL reagents for WFI, Raw Material & finished products.

Quality control in Pharma Microbiology

Sterility test:-

Method Validation.

Stasis test.

Sterility test failure Investigation studies.

Bacterial Endotoxin test (LAL test):-

Method Validation.

Endotoxin Recovery testing.

Endotoxin test failure Investigation studies.

Biological Indicators:-

Qualification of Biological Indicators.

Testing of Biological Indicators.

Work Distribution and Training to New Joiners.

Environmental Monitoring Testing :-

Active and Passive Air Sampling.

Surface Monitoring.

Personnel Monitoring.

Environmental Isolates Identification and Maintenance.

Qualification of Area for Environmental Monitoring Testing.

Environmental Monitoring test failure Investigation studies.

Drain Monitoring.

Trend preparation of the generated data.

Monitoring of NVPC.

Antimicrobial effectiveness testing :-

As per USP and BP.

Disinfectant Efficacy Test :-

Tube Dilution Method.

Surface Swab Method

Others :

Fumigation using fogger & its validation.

Bioball qualification.

Microbial Limit test:-

Method Validation and test method development for various products like: - Chemical Development, Injectables, Ophthalmic, Tablets, and API by pour plate method and membrane filtration method.

Hold time Validation.

Cleaning Verification.

Bio burden method Validations

Pharmaceutical Grade Water Testing:-

Raw Water.

Purified Water.

Water for Injections and Pure steam condensate

Water test failure Investigation studies.

Validation and Qualification of Instruments:-

Media Fill Studies.

Tunnel Validations.

Autoclave Validations.

Air Handling Unit Qualifications.

DHS (Dry Heat Sterilizer).

Pass Box.

Water Qualification.

URS Preparation.

LAF.

Incubators.

Cooling chamber.

Micro pipettes.

Culture Maintenance:-

Preparation of 10-100cfu Inoculums.

Qualification of Media.

AUDIT EXPOSURE:-

Regulatory Audits:-

Costumer Audits:-

USFDA

PMDA

WHO

MHRA

TGA

GSK, Ranbaxy, Baxter, Novartis

Hospira, Biocon.

Bio Pharma, Italy Pfizer

PERSONAL SKILLS AND COMPETENCIES

A balancing team player, good trainer and quick learner.

Time managing person, Out of box thinker and Assertive communicator.

Self–motivated achiever with an established reputation for reliability, hard work, commitment, and flexibility.

Optimistic, dynamic, can easily adapt to environment and changing situation.

RECOGNITION

Recognised as a team player for timely manner release of the qualification activities.

Recognised as best team player for Customer focus and time management.

Recognised and contribution for successful completion of EMEA audit in 2016.

Recognised and contribution for successful completion of PMDA audit in 2017.

Recognised and contribution for successful completion of USFDA audit in 2018.

REFERENCE:

1.Bharathisha BS 2. Narendra Kumar T.N

Manager, QC Microbiology, GM QC Microbiology,

Syngene Limited, Bangalore Wintac Limited, Bangalore

Mobile number: +91-988******* Mobile numbers: +91-988*******

3.Scott Talbot

Vice President Quality and Regulatory Affairs.

Slayback Pharma. US.

Mobile number: +1-954-***-****.

Computer Knowledge: MS Office, well Internet Knowledge and Type Writing.

STRENGTH:-

Optimistic, dynamic, good team worker and quick learner.

Commitment, work-dedication, creativity, Honesty and punctuality.

PERSONAL SYNOPSIS:-

Name

Father’s Name

Date of Birth

Marital Status

Language Known

Permanent Address

: Prashanth N

: Narasegowda

: 22 July 1985

: Single

: English, Hindi, Kannada.

: #2032, Pipeline, Prashanth Nagar, T. Dasarahalli. Bangalore 560057

EDUCATIONAL QUALIFICATION:-

Masters in Microbiology from University of Bangalore in 2008.

Masters in Biotechnology from Kuvempu University in 2009.

Advance Diploma in Clinical Research and Data Management from ICBio in 2008.

Bachelors in Biotechnology, Chemistry and Zoology from University of Bangalore in 2006.

Avowal

I hereby declare that the information furnished above is true to the best of my knowledge.

Place : Bangalore yours truly

Date : Prashanth N

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