Dinesh Koppisetti

**** ****** ********, **********, ******, Ontario

365-***-****

adceb4@r.postjobfree.com

www.linkedin.com/in/koppisettidinesh

Personal Summary:

Experienced Senior Executive with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Method validations, Microbiological testing (antimicrobial effective test, MLT, Bioburden, BET, microbial assay), Water monitoring and testing, Environmental monitoring and Calibrations. Well versed with handling team and have good communication skills with ability to communicate professionally with auditors, management and co-workers. I am looking to continue as a productive team member with a forward-looking company that has ambitions for growth.

Validation Exposure:

PET method validation.

Disinfectant validation.

MLT validation.

Antibiotic assay validation.

BET method validation.

Bioburden validation.

Professional Summary:

Aurobindo Pharma Limited Hyderabad, India

Senior Executive May 2019 - March 2020

Method development for performing microbial assay testing for new products.

Method validation of Antibiotic assay.

Responsible for testing of raw materials, finished products and stability samples for antibiotic assay testing.

Preparation of validated excel sheets for antibiotic assay testing.

Preparing of summary reports for microbial assay testing of various products.

Disinfectant efficacy validations for in-house using disinfectants.

Enumeration of biological indicator

Container closure integrity testing.

Preparation and review of microbiology SOP’s, protocols and reports.

Handling of reference strains, biological indicators and environmental isolates.

Method validation of MLT and bioburden.

Responsible for testing of samples for MLT and bioburden.

Preparation of summary reports for MLT and bioburden testing.

Daily monitoring of incubators and review of incubators temperature data.

Handling of Media stock, BI stock and BET reagents stock.

Preparation and preservation of cryovials.

Determination of Shelf life of in-house prepared media.

Identification of organisms using Vitek 2 compact system.

In-house isolate library preparation.

Performing qualification to individuals for observation of media fill vials.

Verifying the media fill qualification report, updating the list of qualified personnel for routine production batches.

Executive May 2015 to April 2018

Responsible for testing of raw materials, packing materials, finished products and stability samples for Bacterial Endotoxin test.

Responsible for performing method validation of Bacterial Endotoxins per approved protocol or SOP.

Supporting qualification of equipment in microbiology lab

Experience in handling the market complaint samples.

Microbial challenging test for media filled vials.

Observation of Media fills.

Coordinating with cross functional teams (RA and plant QA) for queries and related justifications concerned to Diluents compatibility study.

Monitoring of microbial cultures and handling of Bioballs and their maintenance.

Handling of media

Environmental monitoring

Handling of cultures and culture suspension.

Preparation of summary reports for Antimicrobial Effectiveness Testing.

Responsible of sampling and testing of water.

Planning the personnel qualification for the employee based on the request.

Before planning personnel qualification to ensure the availability of medical reports, clean room trainings.

Updating of qualified list for the clean room of production/microbiology.

Worksheet creation in LIMS or DMS and online documentation of analysis and results.

Online entry of data in LIMS/EM module and COA generation.

Trainee May 2014 to April 2015

Responsible for operation and maintenance of instruments and equipment’s like analytical balance, pH meter, water bath, laminar air flow, pass boxes, incubators, ovens, heating blocks, colony counters and refrigerator

Calibration of balances and micropipettes.

Development of new methods for performing PET study for critical products by coordinating with R&D.

Diluents compatibility study.

Growth promotion test for prepared media and environmental monitoring plates

Responsible for testing and method validation of finished products and stability samples for Preservative efficacy test

Awards and Accolades:

Received UTHAM VYAVAHAR PURUSKAR IN 2017.

Accomplished in ensuring compliance with ISO and other quality standards applicable to industry and participating in audits.

Educational summary:

MSc in Biotechnology in Vellore Institute of Technology (VIT) in 2012

Bachelor’s in Biotechnology, Biochemistry and Chemistry in Loyola Academy in 2010

Work Authorization: Canadian Permanent Residence

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