Research Associate Analytical

Vrushali Sonawane B.S. (Pharmacy)

** ****** **** # * *****: ************@*****.***

Waltham MA 02452 Tel: 617-***-****

Objective : To seek a challenging career in bio/pharmaceutical industry to sustain professional and personal development

Profile

 Bachelor’s degree in Pharmaceutical Science and Technology

 3 years experience in pharmaceutical industry

 Knowledge of formulation dosage forms and design

 Well versed in regulatory documentation and experienced in pharmaceutical analysis techniques

 Expertise in instrumental analysis, wet analysis, validation

 Hands on experience with pharmaceutical instrumentation (chromatographic, spectrophotometric techniques)

 Good knowledge of current regulatory guidelines such as cGMP, cGLP

 Worked in cGMP environment for 3 years

Education

 B.S. in Pharmacy University of Pune, MS INDIA

Employment History

1. QC Chemist, Wintech Pharmaceutical, Nashik, MS India (Sep. 2004 to Dec. 2005)

2. Research Associate, Matrix Laboratories, India (a subsidiary of Mylan Inc. USA) (Dec. 2005 to July. 2007)

Responsibilities:

 In-process and finished product testing

 Raw material testing

 Residual analysis

 Review the QC & QA data in BMR

 Calibration of instruments and performing IQ, OQ and PQ

 Issuing QA documents

 Inspection of CMO's Manufacturing Batch Records

 Environmental Monitoring and Testing, sampling of the water

 cGLP day-to-day activity

 Organizing the up-dation of documents like SOP’s, art works & other applicable documents/records

 Regulatory audit & customer audit preparation

 Coordinating with other departments to get the required work/documents in time

 Maintaining the management information systems and providing the data required for higher management for review meetings as and when required

Instruments handled

 HPLC, UV Spectrometric instruments

 IR analysis

 Polarimeter

 USP Dissolution and disintegration apparatus

 Densitometric analysis

 Karl fischer apparatus

 pH meter & conductivity meter

Professional summary

1. Areas of Technical Expertise

 Pharmaceutical analysis and instrumentation

 Designing experiments, execution, interpreting and reporting results

 Analytical method development and writing SOPs, protocols

2. Areas of Business / Management Expertise

 Productive independent researcher with excellent communication and team skills

 Experience in working with different research groups/projects

 Interacts effectively with the leaders in interdisciplinary departments to achieve results

Legal work-status in USA  Authorized to work in US for any employer

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