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%