Microbiologist with 10 years of exp. Cleaning Validation specialist
Resume:
LALITKUMAR DHONDGE
************@*****.***
SUMMARY
** ***** ** ********** ** QC microbiology and validations.
Investigations and change control writing in TrackWise System.
To design the cleaning method and protocol for new equipments used in manufacturing process.
To establish and validate the Dirty and clean Hold time for manufacturing equipments.
Environment monitoring of manufacturing area.
Identification of environment isolates (BioLog) and EM trend preparation
Microbiological tests.
Swab sampling for chemical and detergent residue and micro content.
Preparation of cleaning validation protocol and summary report
Validation and qualification of newly installed water generation system (Purified and WFI).
Preparation of media fills process simulation protocol.
Media preparation and growth promotion testing
To provide microbiological support to the site ensuring facility and process sterility program compliance to in-house, regulatory requirements.
Experience of handling big team.
Equipments Operated:
pH meter, Conductivity meter, TOC Dissolution Apparatus
UV Spectrophotometer (Make : Perkin Elmer) KFR Autotitrator (Make : Mettler)
Tablet Disintegration Testing.
EXPERIENCE
Qualitest/Par Pharmaceuticals, Huntsville, AL September-2014 to till Date
Project Engineer (Cleaning Validation), Pharmaceutical Technology Dept. (Contractor)
Worked Dust Containment Project. (VAC-U-MAX)
To prepare Cleaning Validation protocols and execution.
To prepare cleaning validation summary Reports.
Directly involved in the installation and qualification of VAC-U-Max and Cremer 8 Head Electronic Bottle Filler.
To design the cleaning method and cleaning validation for new equipments (VAC-U-MAX, Cremer 8 Head Bottle Filler, Charge Hopper, Bellatrx)
Cleaning validations for Tablet Press, Blenders, Coating machines, Servolifts, EHS Drum Inverters and Isolators.
To prepare the cleaning methods and validation protocols for API, Detergent residues and Microbial load based on the equipment product contact surface area. (MARS)
To validate the Dirty Hold and Clean Hold time for equipments.
To coordinate with QC and microbiology laboratory in regards with sampling prep activities and results.
To release the validated equipment for manufacturing purpose.
DPT Labs, Lakewood, NJ
Sr. Quality system Specialist (Contractor) July 2014 to Sept-2014
Investigation writings in TrackWise System.
Internal Audit and to verify the compliance.
To review microbiological method validation data.
To review the batch manufacturing and packaging records.
To review the quality control analytical data.
G&W laboratories, South Plainfield, NJ March 2014 – July 2014
Sr. Microbiologist (Contractor)
Purified water and potable water analysis, viable and non-viable room air testing, surface testing, product and in process liquid bio burden testing.
Media suitability testing, growth promotion of media, incubator maintenance and monitoring.
EM of laboratory and production area, data trending and interpretation.
Microbial Limit Testing on finished products and raw materials.
Antimicrobial preservative efficacy testing. (AET)
Identification of microorganisms by BioLog Identification System.
Investigation of failure(OOS and incidents)
Apothecon Pharmceuticals, Vadodara. Jan 2012 to Dec 2013
Manager Microbiology
Daily planning and allocation of daily work to microbiologists.
Review of analytical reports and validation documents.
Release the finished products and raw materials.
Aurobindo Pharmaceuticals Ltd, Hyderabad May 2010 –Dec 2012
Deputy Manager Microbiology
Teal Leader for a team of 35 microbiologists.
Involved in all kinds of sterile/aseptic validation and qualifications.
Trained the analysts, monitored the daily work, reviewed the analytical data sheets and reviewed the trend etc.
Responsible for the preparation of the sterile process validation and to monitor the execution is done exactly as per the standard procedures.
Other duties included preparation and execution of the scheduling of the internal audits and verifications of the compliance status.
Cadila Pharmaceuticals, Ahmadabad Dec 2008 – May 2010
Asst. Manager Microbiology
Daily planning of environmental monitoring, work allocation trend preparation for environmental monitoring of the production area.
Performed sterility, MLT and BET test method validation for the raw materials and finished products.
Other duties included training of the junior staff and to guide them. SOP preparation.
Investigation of Out of Specification (OOS), handling change control, deviations.
Cipla Ltd, (Oncocare Division) Goa July 2006 – March 2008
Officer Microbiology
Environmental monitoring of production area. Microbiological analysis of WFI, purified and potable water analysis.
Media preparation work which comprises Growth promotion tests/Media suitability test, media stock maintenance and autoclave operation.
EDUCATION
MBA in Total Quality Management, National Education Management, Ahmadabad, India.
MSc in Microbiology Science, Dr. BAMU University, Aurangabad, India.
Bachelor of Science in Microbiology Science Pune University, Pune, India
CONFERENCES, WORKSHOP AND TRAINING:
Pharma prescription training in July 2007 for microbiology in pharma
Attended a training course organised by USP for water for pharmaceutical use in August 2012
Attended Rapid Microbiological Methods workshop organised by USP in May 2013.
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