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Quality Assurance Product Development

Location:
New Brunswick, New Jersey, United States
Posted:
January 23, 2018

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Curriculum Vitae

Anuja Aditya Bhongle

*** ******* **. # ***, *** BrunswickNJ 08901

E-mail: ac35u5@r.postjobfree.com

Contact No: +1-848-***-****

Personal Information

Name: Anuja Aditya Bhongle

Education: Mpharm (Quality Assurance)

Permanant address: 120 Georges RD. # 303, New Brunswick NJ 08901

Language speak: English, Hindi, Marathi

Marrital status: Married

Gender: Female.

Date of birth: 29-12-1991

Objective

To be a part of organization which encourages the initiation drive, recognize human skill, motivation to learn and contribute my abilities to achieve the objective and goals of organization.

Academic background

University/college

Degree

Year

Percentage

Bharati Vidyapeeth University

Bachelor of Pharmacy

2009-2013

67.35 %

Bharati Vidyapeeth University

Master of Pharmacy Quality assurance Techniques

2013-2015

CGPA (9.44)

Professional experience

20 months Experience at Lupin Research Park, Pune.

Position held: Research Associate (Pharma Research)

15th January 2016 to 15th September 2017

Skills and Abilities

ANALYTICAL METHOD DEVELOPMENT:

Good technical experience in analytical method development for the test of -

Assay (Drug content)/ Content per can by HPLC

Aerodynamic particle size distribution (APSD) by NGI and ACI

Dose content uniformity (DCU) by UDD apparatus

Dehydrated alcohol content by Gas chromatography

Foreign Particulate Matter by using HIAC instrument.

Particle size determination (PSD) by Malvern 2000.

Water content by coulometric titration

Identification by UV equipped with UV probe software.

ANALYTICAL METHOD VALIDATION

Performed analytical method validation for the test of -

Assay

APSD, DCU

Water content by coulometric titration, Identification by UV

Microscopic appearance by Motic microscope

Alcohol content by GC

Foreign particulate matter by HIAC.

KEY ACTIVITIES PERFORMED:

Performed drug product characterisation (DPC) study for Cleaning Instruction, Tail off study, Temperature cycling, Drug Deposition on Mouthpiece and/or Accessories, Effect of resting time, Priming Re-priming for MDI product for USA market.

DOCUMENTATION

Preparation of Standard testing procedures (STP) for various MDI products.

To maintain GLP and GDP compliance in laboratory by following established standard operating procedure.

CALIBRATION AND OPERATION:

Calibration and operation HPLC (Shimadzu, Dinox), Coulometer, Ph meter, Analytical balance etc.

Worked on computer software’s like:

MS-OFFICE

CHROMELEON

CITDAS (Copley)

OTHER SKILLS:

Knowledge of the cGMP and GLP practices, Regulatory requirements (like ICH, USFDA, Domestic etc.) of product development for different marketing regions.

Projects/Achievements/Associations/Trainings

M Pharm project: Part A) In-Vitro assessment and impact of Device resistance of different Dry Powder Inhaler Device

In-Vitro evaluation carried out using five different dry powder inhaler devices.

The five devices are evaluated against Tiotropium Bromide Monohydrate using Anderson Cascade Impactor and HPLC as a detector.

Evaluation parameter

1)Fine particle dose

2)Fine particle fraction

3)MMAD

4)GSD

5)Emitted dose

6)Recovered dose

Part B): Method development and validation of Tiotropium bromide monohydrate.

Co- curricular activities:

Presented Research work as a poster in MIT Conference

2014

Presented Research work as a poster presentation in Apticon on simultaneous estimation of pharmaceutical dosage form.

2014

Participated in national conference on Quality By Design

2014

Actively participated in various college conference and programs.

2009-2013

Area of intrest

Research and development(Analytical department)

I hereby declare that, all the above information is true and correct to the best of my knowledge and belief.

Anuja Bhongle

Date:

Place:



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