Pvt Ltd Quality

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Phone No. : 901-***-****,937-***-****

Email : *****************@*****.***

Permanent Address: G/303-Ratnaraj Residency

Sargasan chokadi,behind

siddhraj zori,Gandhinagar -382421

Gujarat,India

ACADEMIC BACKGROUND

Degree Year Of % Secured Class Name of University or

Passing Exam Board

B.Pharm. 2009 64.33% First RGUHS

Class

H.S.C. 2004 53.00% Second GHSEB

Class

S.S.C. 2001 80.00% Distinctio GSEB

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EXPERIENCE SUMMARY

An Experienced and Qualified QA Professional possessing good

communication, interpersonal skills and fulfill with spirit of team work.

Exposed with Quality Management system of large scale drug manufacturing of

Aseptic and Dosages Formulations with in depth understanding of the GXPs

concept define by various regulatory agencies like WHO - GMP, USFDA, MHRA, TGA and ICH. Have hands on experience of preparing and reviewing of SOPs, BMRs, BPRs,Validation Protocols, Reports and Batch documents in the

great sense with latest trends of developed market requirements at present

scenario.

Objective

To reach professional heights in field of quality through dedication and

sincere efforts.

INDUSTRIAL TRAINNING

1. Training Summary: 1 months Training taken for Solid & Liquid Mfg Areas.

Organization : Indamed Pharmaceuticals Pvt Ltd.

Mansa.

EXPERIENCE PROFILE

Duration Company details with Responsibilities and

Position Held

December 2010 to till M/S Unimed Technologies Ltd ( Sun

continue Pharma),Halol Gujarat, India

Responsibilities:

IPQA & Documentation

Last Position Held : Jr Officer - QA

January 2010 to November M/S Claris Life sciences Ltd. Ahmedabad

2010, Gujarat, India

It is a well established pharmaceutical

manufacturer, approved by MHRA UK, TGA

Australia, WHO - Geneva, MCC - South

Africa, ANVISA - Brazil,USFSA -US

Responsibilities :

Validation Activity

Last Position Held : officer 3 - QA

PROFESSIONAL EXPOSURE

1. Preform finished goods inspection and export execution of product

prior to dispatch &, Batch release for packing & finished product (FP

Batch) in ERP system

2. Development and Review of Documents like SOPs, BMRs, BPRs,

Validation Protocols, Summary reports, Reporting Formats and

Checklists to ensure the cGMP compliance .

3. Knowledge of Enterprise resouresing planning (ERP), validation

Master Plan (VMP) .

4. Aseptic Process Simulation ( Media Fill) Study .

5. Observe Redressing activity of finished goods product.

6. Knowledge of Handling of deviations, Change controls, Market

complaints, failure investigations for Root Cause analysis, Self

Inspections and Implementation of corrective and preventive actions .

7. Issue & review of Log Books, Documentation control, retain Sample

control, periodic Inspection of Retain sample,Verification of on line

rejection and Executed BMR Control.closing activity of BMRS and BPRs

8. Observe Personnel Practices in Aseptic Area.

9. Verification of over-printing matter on packing material

10. Updating price list during revision of product price

11. Knowledge of Monitoring of Environment ( Viable and Non Viable,

Pressure Differential, Temperature and Relative Humidity, Area

Cleaning).

12. Check Dispensing Booth and Dispensing area for give area clearance for

Dispenceing of Raw Materials.

13. Withdraw of retain sample & stability sample

15. Performing of different types of validation like,

Washing Validation

Mixing Validation

CIP,Filling Validation

Sterilization Validation

16. Sample analysis during Mixing, Filling, CIP process.

COMPUTER KNOWLEDGE

. Web Technologies: Internet basic concepts

: M.S.Office, ERP, LIMS

PERSONAL PROFILE

Name : Nikhil Thakar

Father's name : Kanaiyalal Somnath Thakar

DOB : 20-09-1985

Sex : Male

Marital Status : Married

Nationality : Indian

Languages Known : Gujarati, English, and Hindi

DECLARATION

I here by declare that the above-mentioned particulars are true & correct

to the best of my knowledge and belief.

Date:

Signature

Place: (Nikhil Thakar)

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