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Nitesh Resume

• Worked with Awamedica Co. Erbil Iraq as Executive - Quality Assurance from 5th Jan 2013 to Dec 2014 and presently working as Sr.Executive - Quality Assurance from 01st Jan 2015 till date. • Worked with Glenmark Pharmaceuticals Ltd, Goa,India as Officer- Quality Assurance from 02nd March 2010 to Dec 2012. • Worked with Geno Pharmaceuticals, Karaswada, Goa ,India as Chemist - Quality Assurance from 02nd May 2005 to Feb 2010. • Worked with Zuari Fertilizers Ltd, Goa, India from 2003 to May 2004.

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190 views3 pages

Nitesh Resume

• Worked with Awamedica Co. Erbil Iraq as Executive - Quality Assurance from 5th Jan 2013 to Dec 2014 and presently working as Sr.Executive - Quality Assurance from 01st Jan 2015 till date. • Worked with Glenmark Pharmaceuticals Ltd, Goa,India as Officer- Quality Assurance from 02nd March 2010 to Dec 2012. • Worked with Geno Pharmaceuticals, Karaswada, Goa ,India as Chemist - Quality Assurance from 02nd May 2005 to Feb 2010. • Worked with Zuari Fertilizers Ltd, Goa, India from 2003 to May 2004.

Uploaded by

Nitesh
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© © All Rights Reserved
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Phone: Mob: 009647508177142

NITESH NAROJI Erbil (whatsapp)


Mob: +91 9890758530 India
+91 99 70723205 Erbil

Email: niteshnaroji@gmail.com

CURRICULAM VITAE

CAREER OBJECTIVE: To obtain a responsible position in a dynamic pharmaceutical company which can
provide an opportunity to fruitfully employ my skills and foster an atmosphere of
continual learning.
CORE AREA OF JOB FUNCTION: Pharmaceutical Quality Assurance

EXPERIENCE SUMMARY IN QA – AROUND 12 YEARS OF EXPERIENCE

 Worked with Awamedica Co. Erbil Iraq as Executive - Quality Assurance from 5 th Jan 2013 to
Dec 2014 and presently working as Sr.Executive - Quality Assurance from 01st Jan 2015 till
date.
 Worked with Glenmark Pharmaceuticals Ltd, Goa,India as Officer- Quality Assurance from 02 nd
March 2010 to Dec 2012.
 Worked with Geno Pharmaceuticals, Karaswada, Goa ,India as Chemist - Quality Assurance
from 02nd May 2005 to Feb 2010.
 Worked with Zuari Fertilizers Ltd, Goa, India from 2003 to May 2004.

JOB RESPONSIBILITY IN CURRENT ORGANIZATION.


 Heading over IPQA section.
 Material code creation (BOM), Product master, Master Formula updation in ERP system.
 Evaluation and approval of change control, Deviation and corrective action and preventive action.
 Administration of Quality Assurance department in absence of Quality Manager,
 Internal Quality Audit on regular intervals .
 Review of batch documents and conduct batch releases.
 Review and approval of BMPR’s, SOP’s, URS, DQ, IQ, OQ, PQ, Validation Protocols / Reports.
 Review and control of production & quality control systems for its adherence to cGMPs
requirements
 Preparation, Execution & Updating of Validation Master Plan, Site Master File

1
JOB RESPONSIBILITY IN GLENMARK GENERICS LTD .
 Heading over IPQA section in absence of Head QA.
 Updating SAP system.
 Performing, documenting and Reviewing In process checks in Manufacturing and packaging areas
of tablets, capsules, semi-solids.
 Providing Line clearance in Manufacturing and packaging of tablets, capsules, semi-solids.
 To perform In process, Process Validation, Cleaning Validation & Cleaning Verification Sampling in
Manufacturing and packaging areas of tablets, capsules, semi-solids as per approved protocol.
 Verification of dispensed raw material in tablets, capsules, semi-solids manufacturing areas.
 Review of cleanliness and environmental conditions in manufacturing area prior to and during
manufacturing.
 Monitoring of destruction/disposal activity.
 To ensure the labeling status of intermediate products / Quarantine/ Finished Products.
 Ensure cGMP compliance during manufacturing processes and report non-compliances to quality
head about the findings.
 Review of BMR and BPR .
 Preparation of Process Validation summary report.
 Preparation of Hold time study Protocol.

JOB RESPONSIBILITY IN GENO PHARMACEUTICALS LTD .


 Performing, documenting and Reviewing In process checks in Manufacturing and packaging areas
of tablets, capsules, semi-solids, Liquids & Injections
 Providing Line clearance in Manufacturing and packaging of tablets, capsules, semi-solids, Liquids
& Injections.
 To perform In process, Process Validation, Cleaning Validation & Cleaning Verification Sampling in
Manufacturing and packaging areas of tablets, capsules, semi-solids, Liquids & Injections as per
approved protocol.
 Verification of dispensed raw material in tablets, capsules, semi-solids, Liquids & injection
manufacturing areas.
 Review of cleanliness and environmental conditions in manufacturing area prior to and during
manufacturing.
 Monitoring of destruction/disposal activity.
 To ensure the labeling status of intermediate products / Quarantine/ Finished Products.
 Ensure cGMP compliance during manufacturing processes and report non-compliances to quality
head about the findings.
 Review of BMR and BPR.

PROFESSIONAL QUALIFICATION

BSc (CHEMISTRY)
Bachelor of Science, from Goa University.
2
AUDITS FACED

In current organization: MOH (Ministry of Health Iraq.)


In Other: ISO14001 2000 WHO, TGA, Uganda, USFDA. MHRA, MCC.

PERSONAL INFORMATION

Permanent Address: Mr. NITESH G. NAROJI


H.N. 150A
Morjim –North GOA.
India

Phone: Mob: 009647508177142 Erbil


Mob: +91 99 70723205

Date of Birth : 29th May 1980


Nationality : Indian
Marital Status : Married
Sex : Male
Language Fluency : English, Marathi, Konkani, Hindi
Leisure Activities : Reading, Singing, Listening to Music, Sports

REFERENCES

Mr.Chandrashekar Pekoda Mr. Ganesh Fasale


Deputy QA Manger Glenmark Generics Ltd .
QA-Manger
Zydus Cadila Healthcare Ltd.

Mob: +91 7066381609 Mob:+91 9421422041

DECLARATION
I hereby declare that statements made here are true, complete and correct as on date to the best of my
knowledge.

Place:
Date: Nitesh Naroji

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