Moumita Mukherjee

** * ******** **, #***, N.Quincy, MA- 02171.

Contact No.-857-***-****

Email id- acrtqd@r.postjobfree.com

Summary:

I am a hard and smart working Quality Control professional carrying out QC lab work from past 3 years. I have excellent hands on experience on analytical instruments like HPLC, UV-VIS Spectroscopy, GC, TLC, and KF. I have developed analytical methods and validation of those methods according to US FDA regulations. I have strong GMP experience and have authored SOP’s, Protocols, Validation reports, Master compliance reports etc. I have excellent communication skills and a self-motivated person willing to always contribute my knowledge in the job I perform. Currently pursuing M.S in Regulatory Affairs in Drugs, Biologics and Medical Devices in Northeastern University, Boston to broaden my knowledge and understanding of current regulations and laws and their practical application in the development and commercialization of drugs, biologics and medical devices.

Education:

M. Pharmacy

Northeastern University, Boston Present

Masters in Analytical Chemistry

SPPSPTM, Mumbai, India 2013

B. Pharmacy

H.K College of Pharmacy, Mumbai University, India 2011

Work Experience:

Evonik Degussa LTD, Mumbai Area, India May 2013 – April 2015

Quality Control Analyst

Experienced in documentation associated with a given product and performing batch record disposition.

Have worked in reviewing and approving deviations, CAPAs, change controls, Product Specifications and any other site/product related documents.

Have worked in conducting inspections to solve the discrepancies and establishing correct methods to reduce errors according to cGMP guidelines.

Have GLP and GMP experience in sampling, sample handling and storage, testing, data review and approval and record archiving.

Equipped with analytical techniques like Assay, Dissolution Tests, Disintegration Tests, Determining water content etc. Trained on handling HPLC and its troubleshooting, Dionex, UV Spectroscopy, Autotitrator, GC, Polarimeter, HPTLC, TLC, LCS, SDS-PAGE, Flash chromatography, Gel Electrophoresis, wet lab chemistry and Elisa reader instrument.

Acquainted with the analysis of extended release, immediate release and delayed release form dosage and experienced in Analytical Method Development and Validation of analytical methods.

Have conducted routine analysis of test samples, raw materials according to standard protocols and methods for product release and validation.

Experienced in creation and editing of quality scientific documents (SOP's, Protocols, Master compliance plans, instructions, guidelines, validation plans, etc.), batch records, record maintenance and audits.

Very strong command in using Microsoft Office skills (Word, PowerPoint, Excel); familiarity with Adobe, Documentum.

Evonik Degussa, Mumbai Area, India May 2012 – May 2013

Project Intern

Analytical method development and validation of assay and related substances of Metoprolol Succinate extended release tablets by RP-HPLC’ in the ADL of Evonik Degussa.

Developed the method of assay and related substances for Metoprolol Succinate extended release tablets which is not present in the USP and validated the analytical method with respect to its specificity, linearity, accuracy, precision, robustness and solution stability.

Pharmacology Dept. at University of Mumbai. June 2010- July 2011

Research Assistant

Worked in the government granted project sponsored by Indian Pharmaceutical Association on ‘Pharmacological screening and acute toxicity study of Eight 4, 5-diarylthiazole urea derivatives for their ACAT inhibitory activity and in vitro free radical scavenging activity in the lab of University of Mumbai.

Nicholas Piramal Research Centre, India

Intern 2011

Developed and prepared ANDA batches, conducted particle size and purity tests of raw materials, learned about GMP documentation in lab notebooks, batch records, protocols and process documents, prepared BMR,SOP and validation reports for product development.

Achievements:

Secured 3rd place at national level for conducting 8 Anti TB campaigns of IPA-SF,2009

Best Student of the State at Rx cultural festival in 2011 held at Bombay college of Pharmacy, Mumbai.

Secured second place for presenting a poster on the topic New Generation of Plastics and their role in Pharmaceutics in Rx festival scientific day.

Presented a poster in IPA-MSB techfest on Tuberculosis and DOTS.

Secured first place in JAM (Just a Minute) talk in Rx festival, 2010.

Conducted 157 No Tobacco campaigns in India, an IPSF project carried out by IPA-SF.

Conducted Blood donation camp at H.K College of Pharmacy.

Articles related to No Tobacco smoking was published in Panache Live Volume 6.

Contact this candidate