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Industrial Training Health

Location:
Pune, Maharashtra, India
Posted:
January 26, 2019

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Resume:

CURRICULUM VITAE

Ms. Sneha Anand Kasbe

Email: ***********@*****.***

Phone No: +91-808*******

Looking forward for Better Prospective, Opportunity & work innovatively Objective

To build a career which enables which enables to expand my professional talent and contribute my wellbeing towards your dynamic, growth oriented organization. Area of Interest

Drug Regulatory Affairs

Pharmacovigilance

Experience

Glenmark Pharmaceuticals Ltd. (Mumbai Head Office) Duration: August 2015- Dec 2017

Job Responsibilities:

Reviewing quality documents like FPS/MoA, COA, AMV, BMR, and BPR etc.

Preparation and filling of CTD dossiers for fresh filing of Dermatology, Cosmetics and Health Supplements, Oncology, Respiratory, Cardiovascular and Diabetic products for Asia Africa, MENA, Russia-CIS and Latam countries.

Preparation and filling of CTD dossiers for renewal filing of Dermatology, Cosmetics and Health Suppliments, Oncology, Respiratory, Cardiovascular and Diabetic products for Asia Africa, MENA, Russia-CIS and Latam countries.

Evaluation of documents and filing variations in Asia Africa, MENA, Russia-CIS and Latam counties.

Response to deficiencies raised by MoH /respective Country Health Authority/ Pharma expertise for submission of dossiers.

Application of Legal documents (Certificate of Pharmaceutical Product, Free sale Certificate, Sworn Statement etc.)

Arranging working Standard/Reference Standards/ Samples required for deficiency response and for filing purpose.

Initiation of Change Control in SAP as per the changes proposed w.r.t Artworks, Registrations and renewals, Change in FPS etc.

Supporting PPIC Team for new product launch.

Artwork correction for new launch/ regular export/ change control etc.

Provide assessment for finalizing the finish product artworks for commercial purpose (carton, label, PI/PIL).

Assist Publishing Team for preparation of e-CTD required for fresh, renewal, variation and responding to deficiencies in MENA region.

Academic Qualifications:

Industrial Training:

1) Cipla Ltd (Mumbai R&D Centre)

2) Twilight Litaka Pvt. Ltd (Mumbai)

M. Pharm Dissertation Details

Title of Thesis: Development and Validation of Stability Indicating RP-HPLC method for the Assay of Anti-hypertensive drug in tablet dosage form.

B. Pharm Dissertation Details

Title of Thesis: A review on Pulsatile Drug Delivery System. Seminars and Achievements:

1) Participated in 52nd National Pharmacy Week 2013 organized by the Indian Pharmaceutical Association.

2) Attended State level Seminar Entitled “Quality by Design” in Pharmaceutical Research and Development.

3) Won 2nd prize in presentation on in vivo- ex vivo absorption study model (simulation) at Bravura Pharma tech Fest 2014.

4) Published article as a co-author Entitled “Studies in Prospective Process Validation of Ranitidine and Ondensetron Combination Injection Dosage Form in World Journal of Pharmaceutical Research.

5) Presented various seminars at college and professional levels. Personal Information:

Name Sneha Anand Kasbe

Contact No. +91-808*******

Date of Birth 06th February 1991

Linguistic Abilities English, Hindi, Marathi

Declaration:

I hereby declare that all the above information is to the best of my knowledge and belief. Date:

Place: Pune Ms. Sneha Anand Kasbe

Qualifications School/ College Board/University Year Percentage M.Pharm (QAT) JSPMS Institutes, Pune Pune 2015 77% B. Pharm JSPMS Institutes, Pune Pune 2010-2013 70.69%

(aggr.)

H.S.C Wilson College,

Mumbai

Maharashtra State

Board

2009 59.33%

S.S.C Gloria Convent High

School, Mumbai

Maharashtra State

Board

2007 66.61%



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