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Quality Assurance

Location:
Kalyan, MH, India
Salary:
2.5 lakh
Posted:
August 04, 2014

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Resume:

DEEPIKA NANDKUMAR BHANUSHALI

B-**/**,Pornima tower.CHS Limited.

Shri ram Krishna nagar,

Klyan,421301 Dist. Thane

Contact no: 909-***-****

E-Mail: ace8g6@r.postjobfree.com

BRIEF OVERVIEW

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Goal oriented professional with over 2.1 years of rich and valuable

experience in Quality Assurance/ Control, & Production. I am looking for

working environment where I can refine up my knowledge and skills further.

EDUCATIONAL CREDENTIALS & TRAINING

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EXAM YEAR

UNIVERSITY / BOARD

% MARKS CLASS Pharma M.BA.

(Correspondence) 2014

IIPM, Lucknow Pursuing - B. Pharmacy 2012 Mumbai University,

Mumbai (M.H.) 57.20 % Second H.S.C. 2008 H.S.C Divisional Board,

Pune (M.H.)

66.67 % First S.S.C. 2006 S.S.C. Divisional Board, Pune (M.H.)

68.93 % First Application filed for the Approval as a Pharmacist in

< Production from FDA (Food & DRUG ADMINISTRATION) from Thane. (M.H)

< Industrial Training programmed at EMIL PHARMACEUTICALS, Boisar

(Thane) for period of one month in various department like production,

Quality control,, packaging and other from 16th may 2011 to 15th

June 2011 & Industrial visit to Associated Capsule Group Plant Dahanu

as a part of curriculum.

< Impart Training in Manufacturing of Parental Products.

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CAREER CONTOUR

Currently working as an Senior Officer in Quality Assurance / Control

Department from June-2012 to till date at Viridis Biopharmaceutical Pvt.

Ltd. at Mumbai. It is well established & fast growing Formulation which is

manufacturing Sterile as well as non sterile pharmaceutical dosage forms.

It is ISO & GMP certified facility at Dist: Thane (M.H.)

RESPONSIBILITIES

Quality Assurance & Production {Solid & Semisolid}

< Preparation, Approval, Issuance, Review & Closing of, MFR, BMR and BPR

< Verified Certificate of Analysis (COA) of finished product.

< Batch completion intimation& Batch Release/Dispatch Check List.

< Handling of change control and deviations.

< Preparation, review & approval of Site Master File of plant.

< Preparation of annual product review (APR).

< Preparation of process validation protocols and reports.

< Preparing a framework of quality standard procedure (SOP), work

instructions and formats for addressing the all std. requirement and

overseeing smooth implementation.

< Collection, recording & periodical checking of control samples.

< Participating in production planning & update price list of product.

< Line Clearances

< IPQA Activities

< Prepared labels & pasting and sealing.

< Job order & Stock return of RM and PM.

< Checking log sheet of temperature and humidity.

< Completion of rejection analysis chart

< Reconciliation & Raw & Packing materials.

< Carrying Out And Supervising Processes Like The Dispensing Of Raw

Materials, Granulation Process, Compression, Coating

< Checking Of The Various Parameters Of Tablets At Each Stage And Maintain

them Within Limits.

Quality Assurance & Production {Parenterals Product }

< Aseptic area monitoring.

< Handling of In process test for parental product.

< Handling of Washing, Filling and Manufacturing Department.

< Skilled in BMR/BPR filling, Checking & Reconciliation.

< Water validation

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Audit faced

< ISO (INTERNATIONAL STANDARD ORGANIZATION) 13485 by UL

< FDA(Food & Drug Administration)

< Dr.Reddys

< Aristo Pharmaceuticals

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Quality Control

< Review & issuance of the SOP's of Quality control department.

< Handling of Environmental monitoring, fumigation.

< Pathogenic testing & Total Microbial Count of Finished Product.

< Sterility & Log Reduction Test for Sterile finished product.

< LAL Test & BET for Sterile product.

< Preparation & Updating of specification and method of analysis as per

IP, BP & USP.

< Analysis of RM/PM, In-process & Finished Product as & when required

< To monitor the stability studies data.

< COA review of starting material, packing materials, intermediate, bulk

and finished products.

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IT FORTE

Well versed with MS Office, MS Excel, Power point, Internet Applications.

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PERSONAL SNIPPETS

Date of Birth: 24th September 1991

Permanent Address: Opposite to coco cola company, Anamika complex,

Dist-thane, 421303

Languages known: English, Hindi, Marathi, Gujrati

Reference:

1. Prashant Bonde

2. Bhushan Mokashi

Ass.QA Manager,

H.R. & Admin Department

Viridis Biopharma Pvt Ltd, Wada

Viridis Biopharma Pvt Ltd, Wada

Mob. 727-***-**** Mob.

996*******

DECLARATION:

I hereby inform that the information mentioned above is true to the

best of my knowledge.

Date;25/07/2014[pic]



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