Resume

Name Babu M
Mobile Number 09035019783
Email ID babureddy_micro@yahoo.co.in
Fathers name Muni Reddy N
Date of Birth 19.11.1983
Marital status Married
Personal 3/218-8,Ragavendra Nilayam, Arasanatty,
Profile
Mookandapalli,Hosur 635126.
Present Address
Krishnagiri.
Tamil Nadu

3/218-8,Ragavendra Nilayam,Arasanatty,
Mookandapalli,Hosur 635126.
Permanent Address
Krishnagiri.
Tamil Nadu

Educational Master of science in Microbiology (First Division)

Post Graduation
Profile Periyar University, Salem.(2005-2007)

Languages Known English, Telugu, Tamil ,

Kannada and Hindi

Biocon Limited,
Bangalore, Deputy
Manager QC
Microbiology, from
January 2015 to till date.
Mylan laboratories ,
Bangalore, Senior
Executive
Professional Profile Microbiology , from
July 2009 to Dec -2014
V B Medicare Pvt Ltd,
Hosur As a
Microbiologist -
Microbiology from
August 2007 to July
2009.

Responsible for
Microbiology
laboratory
function and
leading a team
comprising of
15 members in
Biocon ltd.

Monitoring of
facility
qualification,
systems,
equipment,
production &
process flow
and conducting
simulation
trials for
ensuring
aseptic
practices and
controls.

Effective
implementation
of QMS.

Review, Root
cause analysis,
Investigations
and
implementation
of CAPA for
OOS, OOT and
Deviations.

Imparting
continuous
training,
motivation and
review of Best
Microbiological
practices and
 Aseptic
Present practices for
Responsibilities Laboratory,
Production,
Engineering
personnel.

Developing
procedures for
laboratory
management,
test method
validations,
personnel
competency
verification in
line with the
current
expectation &
regulatory
requirements.

Implementation
of LIMS as a
part of
continual
improvement
for
Environmental
and utility
monitoring.

Participation in
regulatory
submissions
and response to
regulatory
queries /
deficiencies.

Active member
of Management
review
committee for
reviewing the
 state of control
of the systems
and
improvement
programs.

Endotoxin
testing and
method
validation by gel
clot..

Disinfectant
Efficacy Test.

Microbial
limit testing and
its method
validations as
per pharmacopial
requirements

Water
analysis.

Culture
handling and
maintenance.

Identification
of
Environmental
isolate and lab
cultures up to
Species Level.

Environmental
Technical Expertise monitoring for
sterile bulk and
sterile dosage
manufacturing
areas (Personnel
Monitoring, Air
sampling, Settle
plate).

Trend
preparation of
the generated
data.

Validation
and calibration
of
Microbiological
equipments
and
instruments like
Autoclave. DHS,
Incubators,
identification
systems etc.

Effectively
using risk
assessment tools
to enhance the
sterility
assurance level.

Review of
Laboratory
Incidents and
Deviations

Review of
process
validation
protocols and
reports.

Preparation
of hormonized
procedures and
review of QC,
QA SOPs.

Review of
Microbiological
reports.

Review of
Change controls.

Actively
involved in
preparation of
audit responses
 Periodic
review of Alert
and Action limits
with
implementing
effective CAPA
if any.

Preparation
and review of
Equipment
qualification
documents.

Identification
of gaps using
risk assessment
tools for Aseptic
processing steps
and
implementation
of effective
control
measures.

Harmonization
of SOPs and
Validation
Protocols across
Responsibilities the Plant.
Handled
Work
distribution to all
Microbiologists.

Actively
participating in
internal and
external audits.

Preparing
strategies for the
success of
various national
and international
audits.

Training to
the employees on
 various skills
like BET, MLT
and Aseptic
behavior in clean
rooms.

Implementation
and review of
cost saving
projects in
Microbiology
laboratory.

Actively
participating in
planning and
execution of
media fill
activities.

Review and
authorization of
documents and
records.

Documentation
preparation in
line with current
industrial
standards and
regulatory
expectation..

Implementation
of MODA for
the EM and
utility
monitoring.
Audit Exposures
US FDA

.MHRA

TGA audit,

ANVISA

Various
Customer
 Audits.
Hobbies
Playing
Cricket.

Riding Bike.

M Babu.

Mobile: 09035019783

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