SHRIDHAR Y.PATIL

**,****** **** ******* ***-karaveer Dist-Kolhapur

Contact No: 976-***-**** & 950-***-**** Email:acr0ye@r.postjobfree.com

MICROBIOLOGY QUALITY CONTROL

Offering experience across the Microbiology area

PROFILE

An articulate Master of Microbiology with career success across different Microbiological area. Currently associated with Lupin Limited, Goa as junior executive Quality Control department (Microbiology section).

Rich knowledge-base founded on curriculum as well as through hands-on job experiences,

Quick learner, innovative & detail oriented with reputation of unwavering accuracy, credibility & integrity.

PROFESSIONAL EXPERIENCE (4.10 yrs. in sterile as well as non-sterile pharmaceuticals)

CIPLA LIMITED, GOA

Quality Control: Microbiology Section Jan’11-Sep2013

Oncocare Division (Sterile and Non sterile)

Cipla Oncocare division, a world class facility having approval of US FDA, TGA, ANVISA, MCC, WHO

And MHRA. Manufacturing the life saving parenteral, tablet and capsules.

MARCK BIOSCIENCE LTD GOA Sep13-May14

Quality Control: Microbiology Section

Large volume parenteral (Sterile)

LUPIN LIMITED, GOA May14-Till date

Quality Control: Microbiology Section

Documentation:

Change control:-Document related, Instrument related change control etc.

Deviations : Planed,unplanned deviation.

Investigation of Product, water etc failure and resolution,(OOS,OOT Investigation and resolution)

IQ,DQ,OQ,PQ of instrument (Incubator,colony counter, anaerobic jar etc)

Preparation and updations of TDS as per new guidelines.

Preparation of validation Protocol and Reports.

Training on standard operating procedure and there implementation.

Software known : Total Quality Control(TQC) and Quality Control Management system(QCMS),SAP

Validation:-

Validation of aseptic process (Media fill)

Disinfectant Validation (Surface challenge and dilution).

Water system validation.

Sterility Method validation

BET Method validation.

Bioassay method validation.

Autoclave validation.

DHS validation

Bioassays excel sheet preparation and validation.

Bulk Bioburden method validations (Injectable).

Culture density study

Validation of Remelting of media

Validation of fumigation by fogger.

Bio ball recovery study

Preservative efficacy Test.

Sterility :-

Close Canister Methods

Open Methods

Direct inoculation methods

BET:-

BET of raw materials, finished products Stability product, Water sample.

Spiking and recovery of endotoxin in tunnel validation process.

Bioassay:-

Bioassay of raw material, bulk, finished product as per IP,B.P and USP

Water Analysis:-

Analysis of potable water, purified water, water for injection and pure steam

Media preparation :-

Media preparation

GPT and GIT

Non-Routine

Event and data management of Incubators(Data Logger)

Container Closure Integrity test.

Post fertility of media filled vials.

Coliform testing.

Analysis of Biological Indicators(Verification of spore count)

Bioburden analysis of different In-process Bulk.

Bioburden analysis of different Packing materials (Primary and Secondary) used in both sterile and non sterile facilities.

Receipt of microbial cultures, purity check, maintenance and record updations.

Sub culturing (Passages), broth culture preparation and Total viable count (TVC) of Standard and in-house organisms.

Calibrations:

Balance, Microscope, antibiotic Zone reader, Research pipette, Colony counter.

Identification: I

Identification of microorganism by Vitek-2 Compact, BBL crystal mind.

Sound knowledge of environment monitoring of production area (sterile and non-sterile facilities), Sufficient knowledge of Media fill process, limits and acceptance criteria, Microbial limit test

EDUCATIONAL DEVELOPMENT

Master Of Science (Microbiology) 2010

First class, Krishna Medical College, Karad, KIMS University

Bachelor Of Science ( Industrial Microbiology) 2008

First class, Rajaram College, Shivaji University, Kolhapur

Higher Secondary Certificate 2005

First class, Maharashtra State Board

Secondary School Certificate 2003

First class, Maharashtra State Board

COMPUTER SKILLS

MS-CIT, MS Office – MS Word, MS Excel, MS PowerPoint

PERSONAL

Date Of Birth: 4th Nov, 1987

Language Proficiency: Marathi, Hindi, English

Reference: Available on request

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