Pvt Ltd Manager

RESUME

Nilesh L. Patel.

Permanent Address: F-33, Arjun apartment,

Near Suryanarayan Society,

Arjun Tower road,

Ghatlodia-380061,

Ahmedabad.

Mobile No. : 989-***-****, 972-***-****

E-mail : **********@*****.**.**

* Personal Profile:

> Date of Birth : 22 April 1981

> Gender : Male

> Languages Known : Gujarati, Hindi, English

> Hobbies : Reading, Singing, Drawing & Sports

> Passport No. : E-5436688

> Marital Status : Married

> Nationality : Indian

> Present Address : F-33, Arjun apartment

Near Suryanarayan

Society,

Arjun Tower road,

Ghatlodia-380061.

* Key Responsibilities:

ZYDUS HOSPIRA ONCOLOGY PVT LTD:

Q.C SHIFT INCHARGE EXECUTIVE

> To follow the Good Laboratory Practice and Good Documentation Practice

in the Laboratory

> Initiate change control,Deviation, CAPA, Training,OOS,LIR for

any change,result deviation, new sop preparation, OOT stability data

.Also review related activity data and LIMS data,sign off and submit

to QA For final compilation.

> To procure required material for the chemical and instrumental

testing.

> Review the finished product reports and release as per

specification of product

> Plan samples for testing to analyst & follow up to release. Give

training to new personal in QC as per his job description & do

analyst qualification.

> Method transfer of Irinotecan and Epirubicin from ZHOPL to Hospira.

> To record all the data related to the testing online and day-to-day

basis and ensuring the tractability of it.

> Review and ready auditable documents like:

1. CERTIFICATE OF Standard Weight of Balance (use in daily

calibration of Balance)

2. Third party calibration report of Thermometer.

3. Preventive Maintenance report from Service Eng. Of different

instrument reports, in Quality control (instruments used in QC)

4. Keep ready PM schedule of instruments calibration schedule and also

list out current spares available for each instruments yearly.

5. Check expiry date of Working standard, chemicals,calibration date

etc

DISHMAN PHARMACEUITCALS AND CHEMICALS LTD:

R & D : ANALYTICAL REASEARCH ASSOCIATE

> New project online monitoring OF Reaction mass, intermediates, crude,final product, on HPLC, TLC, M.P, KARL FISHER, TITRATATION METHOD.

> Develop method for separate new impurity isolation on HPLC and TLC,

updating hplc method for minimize testing cost.

> Also do other test like,Melting point, Moisture of product or RXM,LOD, Titrimetric assay

> To carry out the calibration of HPLC, KARLFISHER, pH METER, BALANCE

as per the schedule

ZYDUS HOSPIRA ONCOLOGY PVT LTD:

Q.C ANALYTICAL EXECUTIVE

> Testing of Finished-product,Raw-Material, Process Validation samples

and Method d validation of New product

> Follow the specification of product and GDP, GLP requirement during

testing and reporting .

> Maintain all records related to product analysis.

> Update knowledge as per new guideline.

> Calibration of HPLC and Gas chromatography.

> To record all the data related to the testing online and day to day

basis and ensuring the tractability of it.

TORRENT PHARMACEUTICAL LTD:

Q.C.EXECUTIVE

JUL 2006 TO APR 2007: AS EXECUTIVE IN US DEPT IN HPLC

> To carry out testing of the materials according to standard operating

procedure of RM, PM and FP or API .

> To record all the data related to the testing online and day to day

basis and ensuring the tractability of it.

> To carry out the calibration of HPLC as per the schedule.

> Tech transfer of Pramipaxole,Pantoprazole,Citalopram etc.

> To carry out the In Process Product testing during manufacturing of

all products.

APR 2007 TO MAR 2009: AS A SHIFT INCHARGE EXECUTIVE REVIEWER IN US

DEPT IN HPLC

> Plane work to analyst in shift as per priority given by Manager as per

production schedules.

> Manage communication with analyst Manager or production chemist or QA

person for emergency of result without affecting GLP compliance or

quality result.

> Prepare summary of online result for in process batch Stability batch

for easy trend Analysis.

INTAS PHARMACEUTICAL PVT LTD

> I have worked in Finished product, Granules (in process) like

Tablets, Capsules and Injectable products.

> To carry out the Testing on UV for ASSAY, DISSOLUTION(Profile and FP)

and, C.U. TEST, Uniformity of weight, Disintegration, Friability,I.R, etc.

> To prepare the working STD and reconcile the same.

> To carry out the In Process Product testing during manufacturing of

all products.

. Instrument Area:

I can operate all sophisticated Instruments like HPLC, Disolution, M.P,

I.C, UV Spectrophotometer, GC, FTIR, Karlfischer Titrator, Culometer, TOC

etc

. Laboratory software: SAP,LIMS

.

* Working Experience: TOTAL: 10 YEAR

Presently working with Zydus hospira oncology pvt Ltd., at Bavla Ahmedabad.

Here I am working as EXECUTIVE LAB

+ INCHARGE.

From JAN 10 to Working with Dishman pharma Working as ANALYTICAL

and chemical ltd RESEARCH ASSOCIATE

26 December Bavla.

From March 09 Working with Zydus Working as QC Executive

to Hospira oncology Pvt Ltd

JAN 10 Matoda.

From Jul 06 to Working with Torrent Working as QC Executive

March 09 Pharmaceutical Ltd.

Indrad

From Aug 04 to Working with INTAS Working as QC Officer

Jun 06 Pharmaceutical Ltd.

Matoda

( Academic profile :

Degree University Year Division

M.Sc. North Gujarat 2003 Second

(ORG.CHEM.) University

B.Sc. North Gujarat 2001 Second

(CHEMISTRY) University

* Strength:

> Leadership Quality and Management Ability.

> Zest Ambitious.

> Positive Thinking.

* Award Received:

> Received the "Very Good Category " Certificate from Torrent

pharmaceuticls Limited,

in both year 2007 & 2008 for USFDA AUDITS related work.

* Audit faced:

1. USFDA

2. MHRA(UK)

3. MCC(SOUTH AFRICA)

4. TUNISIA

Passport Details:

Passport No: E5436688

Passport Issued in : India

Passport Issue Date:15/07/2003

Passport Expiry Date: 14/07/2013

Language Skills:

English:

Read: [pic]

Write: [pic]

Speak: [pic]

Hindi:

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Hindi:

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Personal:

Gender: M

Age: 30

Height: 5'4"

Weight: 50 kg

Maritial status: Married

No of Dependents: 3

Driving Licenses:

Country of issue:INDIA

Type:MIC EX50CC WI GR

GCC Lic. :GJ24/017285/08

Light Vechice (Expired last year)

24/11/2028

India

Light Vehicle

Valid

* References:

> Mr. Shardul Pandya

Manager - DGM,

Zydus cadila pharma. Ltd. .

> Mr Babubhai patel

Head - ADL LAB,

Dishman pharma. Ltd.

From:

Nilesh Patel

Place : Ahmedabad

Date:

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