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Manager Quality Control

Location:
Mumbai, MH, India
Posted:
June 25, 2014

Contact this candidate

Resume:

Application for the post of

"MICROBIOLOGIST".

Dear Sir/Madam,

I P.Hari prasad babu from Bangalore, INDIA, presently i am

working as a Sr. Executive (Team leader) in Quality control

Dept with HIMALAYA DRUG COMPANY. BANGALORE. Leading cosmetic and

pharmaceutical manufacturer in INDIA.

I completed my masters in MICROBIOLOGY, having 8 years experience in cGMP,

US FDA, MHRA, TGA, ISO, regulated environment for consumer and pharma

industry. Also having strong working knowledge of quality control tests

like, Microbiological tests (sterility, assays of antibiotics, lactic acid

bacillus test, microbial limit test, assays of vitamins, staining

techniques, ELISA, Bacterial endotoxins test, Environmental monitoring in

cleaned rooms, PET Test, identification of microorganisams,GPT Test, water

analysis.) Also having experience in Instrumental analysis (HPLC, GC,

FTIR, AutoTitrator, UV- VIS.Spectrophotometer, refractometer, density

meters, polarimeter.), and wet chemistry analysis of pharma products. Also

having experience in sampling activities for microbial and chemical

analysis.

Having experience in analytical method development/validation activities,

Practical understanding and experience resolving analytical testing

deviations (OOT, OOS, etc.) root cause investigations and effective CAPA's.

Having experience in cGMP, GLP, GDP.Also giving training to new joins.

I herewith enclose my resume for your kind perusal. I would appreciate the

opportunity to discuss my experience for this position in detail.

Thank you for your kind consideration and look forward to hear from you.

Thanking you,

Yours sincerely,

P. Hari prasad Babu.

+91-974*******.

CURRICULAM VITAE.

P.HARI PRASAD BABU, Msc,

(Sr.Executive),

(8 Years experience),

HIMALAYA DRUG COMPANY,

BANGALORE-560054, Mobile: +91-

974*******.

INDIA.

Email: acepx7@r.postjobfree.com

OBJECTIVE:

A challenging and growth oriented position where may I enhance skills

and capabilities for implementing desired organization strategies. Willing

to work in challenging & creative environment where I can learn as well as

contribute towards betterment of my organization and society as well. I

want to attain a challenging position to make company and myself grow

simultaneously.

JOB RESPONSIBILITIES:

. Media preparation.

. Culture maintenance, Preparation of Culture Suspensions and performing

of GPT for regular Media.

. Water sampling & Microbiological Water Analysis.

. Environmental Monitoring by Settle Plate Method, Volumetric Air

Sampling, Surface Swab Method & Personal monitoring.

. Microbial limit Test of Raw Materials and Finished products.

. Performing of Preservative Efficacy Test for regular products.

. Container Closure Integrity Test of filled and sealed vials.

. Identification of Environmental & Water isolates and lab cultures up

to Species Level.

. Bioburden testing of In-Process samples.

. Preparation of monthly Trends of Water, Settle plate, Air sampling &

Compressed Air.

. Compressed Air Sampling & Analysis.

. Knowledge in Bacterial Endotoxin testing and Sterility testing.

. Handling OOS, OOT'S, and CCF'S and finding root causes.

. Identifying of microorganisms by using BIOMERIUX VITEC-2 system.

. Sanitary assessment by drainage swabs and machine swabs.

. Review and checking of work sheets.

. Performing environmental monitoring of sterile and non-sterile areas

by settle plate method,

Hi Petri air sampling, swab methods, documenting and trending

results.

. Biological assays to estimate vitamin concentration

. Chemical analysis of raw materials, in-process and finished products

. Maintenance of personal hygiene by using contact plates (Finger dab

test) and taking swabs from hands, gloves and from uniform.

. Estimation of gluten content by using ELISA technique.

. Disinfectant validation study.

. Preparing documents for the above listed microbiological operations

and maintenance of all microbiology records.

VALIDATIONS:

. Area Qualification by Microbiological methods.

. Water System validations.

. Qualification of Biological Indicators for Dry Heat & Moist heat

Processess.

. Media shelf life validation

. Glassware and Garment Hold Time Study.

. Disinfectant Validation.

. Microbial limit test validation.

. Sterility test validation.

. U.V. Efficacy Studies.

. Qualification of Laboratory requirements like Gloves, Readymade Media

etc,

. IQ, OQ & PQ of Laboratory Equipments.

Analytical SKILLS:

. Calibrations of HPLC, GC, FTIR, UV- Visible Spectrophotometer, Auto

Titrator and other instruments,

. Maintenance of lab instruments and trouble shooting in analysis,

. Preparation of standardization of volumetric solutions,

. Preparation of working standards, Preservation of control sample.

. Analysis of raw materials, finished products and reaction

intermediates by HPLC.

. Polarimeter, Refractometer, Density meter. Melting range, moisture

content,

Loss on drying, standardization, titration and extractions.

Documentation skills:

. Preparation of calibration records for all lab instruments

. Preparation of standard operating procedures (SOP'S).

. Preparation of certificate of analysis (COA).

. Preparation of working standard records.

. Maintain and update general documents.

. Prepare test protocols and reports of validation projects.

COMPUTER SKILLS:

. Working knowledge on MS-Office,

. Working with Laboratory Management information system (LIMS.),

. Working with SAP,

. Browsing internet for learning and processing of new

information.

personal STRENGTHS:

. Good communication skills, ability to maintain a positive attitude

in the face of changes in

Work assignments, self motivated, adaptive and innovative, quick

learner, hardworking and

Dedicated. Sportive and adjustable mind power.

. Strong, demonstrated knowledge in Microbiology systems, genuinely

interested in personal and

Team development.

. Implementing new rapid microbiology techniques and reducing cost,

manpower,

And minimize business losses associated with microbial

contamination.

. Ability to work at any circumstances and acclimatize quickly.

Having good communication and presentation skill.

. Demonstrated capability to lead work across multiple categories/

Business units in order to develop and implement standard

approaches.

PROFESSIONAL EXPERIENCE

. Presently I am working with "HIMALAYA DRUGS COMPANY "as a Sr.executive

(Team leader.) From September 2011 to till date. (A cGMP compliant

company).

. I have worked as a" Jr.Manager "from January 2009 to September 2011 for

DR. REDDYS

LABORATORIES an USFDA certified pharmaceutical company. A cGMP

compliant company.

. I have worked as a "Sr.CHEMIST" from June-2006 January 2009 for

VIMALA

SCIENTIFIC SERVICE PRIVATE LTD., an ISO 9001 certified quality

control laboratory

Involved in analysis of Water, Pharmaceutical and Bio-

Pharmaceutical Substances.

EDUCATIONAL QUALIFICATIONS

. M.Sc. (Master of Science) in Microbiology from A.M.C College,

Bangalore.

. B.Sc. (Bachelor of Science) from P.V.K.K. Degree College, Sri

Krishnadevaraya University, Anantapur, with specialization in

Microbiology, Botany & Chemistry.

. Intermediate from St.Joseph's Junior college, Kadapa, with the options

of Biology, Physics & Chemistry.

. S.S.C. (Board of Secondary School Certificate) from A.P.R.S,

Kodigenahalli, Ananthapur.

Personal DETAILS:

Name : P. Hariprasad Babu

Fathers Name : P. Narasimhulu

Mothers Name : P. Lakshmi Devi

Marital status : Married

Nationality : Indian

Present address : H: NO: 48,

(Upstairs.),

11

Th Main, 1st ROAD,

MATHEKERE,

BANGALORE-500054.

INDIA.

Permanent Address : Katarupalli (Post & Village),

Kadiri (Tq),

Anantapur (DT) - 515521

Language Proficiency : Fluent in reading and writing

English, Hindi

And Telugu.

REFERENCES:

1.

Durgaprasad.jha, (Manager)

Quality

control Department,

HIMALAYA

DRUG COMPANY,

MAKALI,

BANGALORE.

INDIA.

Mobile:

096********,

E-mail:

acepx7@r.postjobfree.com

2.

Ratna kishore, (Assit.Manager ),

Quality

control Department,

Dr.Reddy's laboratories Pvt Ltd,

HYDERABAD.

INDIA.

Mobile: 996-***-****.

DeclaraTION

I hereby declare that the above particulars are true to the best of my

knowledge and belief.

Date : 25-06-2014.

Place : Bangalore. (P. HARIPRASAD

BABU).



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